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2026 data FDA MAUDE openFDA FDA Class II

Appliance, Fixation, Spinal Interlaminal

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3050 (Orthopedic panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Appliance, Fixation, Spinal Interlaminal MID-BOOK · MAUDE

#175 of 1000 · 14,567 reports · 1993–2026

  • BOOK 14,567 reports
  • RANK #175 of 1000
  • DEATH 40 death-typed
  • INJ 7,674 injury-typed
  • MALF 6,714 malfunction
  • SPAN 1993–2026
  • PEAK 2016: 1,379
  • PHOTO Pulse Generator

Nearest event-volume peer: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (73 report gap)

Appliance, Fixation, Spinal Interlaminal sits #175 of 1000 among tracked device types with 14,567 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Appliance, Fixation, Spinal Interlaminal carries 52.7% INJURY-coded reports, 22.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 52.7% corpus 30.3% · above corpus mean (+22.4 pp)
  • MALF 46.1% corpus 64.8% · below corpus mean (-18.7 pp)

Lead product-problem code Break is 30% of coded problems · Lead manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG accounts for 54% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Appliance, Fixation, Spinal Interlaminal in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Appliance, Fixation, Spinal Interlaminal carries 14,567 MAUDE reports, ranked #175 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 7,674 (52.7%)
Malfunction 6,714 (46.1%)
Other 70 (0.5%)
69 (0.5%)
Death 40 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

6,496 (42.0%)
Required Intervention 6,092 (39.4%)
Other 1,501 (9.7%)
R 685 (4.4%)
Hospitalization 315 (2.0%)
H 92 (0.6%)
Disability 79 (0.5%)
O 78 (0.5%)
S 55 (0.4%)
Death 41 (0.3%)
Life Threatening 16 (0.1%)
L 11 (0.1%)
Not Applicable 5 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Break 4,220
Adverse Event Without Identified Device or Use Problem 1,403
Failure to Align 1,350
Migration or Expulsion of Device 1,069
Device Slipped 968
Explanted 752
Fracture 521
Device Dislodged or Dislocated 494
Replace 471
Material Deformation 400
Loose or Intermittent Connection 373
Detachment Of Device Component 342
Loose 280
Migration 278
Implant breakage or physical damage 256
Loosening of Implant Not Related to Bone-Ingrowth 256
Insufficient Device Problem Information 244
Mechanical Problem 207
Appropriate Device Problem Term/Code Not Available 198
Malposition of Device 198

Yearly Trend

93
1993: 3
94
1994: 7
95
1995: 1
96
1996: 6
97
1997: 87
98
1998: 65
99
1999: 79
00
2000: 40
01
2001: 24
02
2002: 21
03
2003: 40
04
2004: 60
05
2005: 150
06
2006: 94
07
2007: 210
08
2008: 594
09
2009: 682
10
2010: 474
11
2011: 793
12
2012: 918
13
2013: 1,090
14
2014: 1,022
15
2015: 1,348
16
2016: 1,379
17
2017: 864
18
2018: 657
19
2019: 518
20
2020: 796
21
2021: 525
22
2022: 335
23
2023: 332
24
2024: 436
25
2025: 501
26
2026: 416

Reports in 2025 (501) held close to the prior two-year average of 384.

Related Entities for Appliance, Fixation, Spinal Interlaminal

Top Manufacturers

MDT SOFAMOR DANEK PUERTO RICO MFG 2,910
MEDTRONIC SOFAMOR DANEK 1,278
SYNTHES USA 457
MEDTRONIC SOFAMOR DANEK USA, INC 438
SYNTHES (USA) 324

Event Locations

7,812 (53.6%)
I 5,586 (38.3%)
HOSPITAL 789 (5.4%)
OTHER 235 (1.6%)
NO INFORMATION 56 (0.4%)
HOME 38 (0.3%)
INVALID DATA 22 (0.2%)
CLINIC - WALK IN, OTHER 14 (0.1%)
AMBULATORY SURGICAL FACILITY 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
NOT APPLICABLE 2 (0.0%)
UNKNOWN 2 (0.0%)
0 1 (0.0%)
OUTDOORS 1 (0.0%)

Compare MDT SOFAMOR DANEK PUERTO RICO MFG vs MEDTRONIC SOFAMOR DANEK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Appliance, Fixation, Spinal Interlaminal: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (14,567 here).

Pulse Generator 14,494 Lift, Patient, Non-Ac-Powered 14,697 Device, Vascular, For Promoting Embolization 14,423 Set, I.V. Fluid Transfer 14,331

Similar death-typed counts

Nearest other device types by death-typed report count (40 here), distinct from the volume row.

Applier, Surgical, Clip 40 Pacemaker Lead Adaptor 40 Prosthesis, Hip, Femoral, Resurfacing 40 Walker, Mechanical 40

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Appliance, Fixation, Spinal Interlaminal are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Appliance, Fixation, Spinal Interlaminal; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.