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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#173 of 1000 · 14,243 reports · 1993–2026

  • BOOK 14,243 reports
  • RANK #173 of 1000
  • DEATH 40 death-typed
  • INJ 7,453 injury-typed
  • MALF 6,611 malfunction
  • SPAN 1993–2026
  • PEAK 2016: 1,379
  • PHOTO Single Use Only Blood…

Nearest event-volume peer: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (187 report gap)

Appliance, Fixation, Spinal Interlaminal sits #173 of 1000 among tracked device types with 14,243 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 52.3% corpus 30.4% · above corpus mean (+21.9 pp)
  • MALF 46.4% corpus 64.5% · below corpus mean (-18.1 pp)

Lead product-problem code Break is 30% of coded problems · Lead manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG accounts for 40% of manufacturer-tagged reports · Top event location is 53% 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 14,243 MAUDE reports, ranked #173 of 1000.

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

Event Types

Injury 7,453 (52.3%)
Malfunction 6,611 (46.4%)
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.

6,400 (42.4%)
Required Intervention 5,891 (39.0%)
Other 1,494 (9.9%)
R 665 (4.4%)
Hospitalization 302 (2.0%)
Disability 77 (0.5%)
O 68 (0.5%)
H 60 (0.4%)
S 54 (0.4%)
Death 41 (0.3%)
Life Threatening 16 (0.1%)
L 10 (0.1%)
Not Applicable 5 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Break 1,934
Failure to Align 729
Adverse Event Without Identified Device or Use Problem 633
Migration or Expulsion of Device 440
Device Slipped 413
Material Deformation 327
Fracture 316
Device Dislodged or Dislocated 267
Migration 262
Loosening of Implant Not Related to Bone-Ingrowth 230
Loose or Intermittent Connection 178
Mechanical Problem 150
Appropriate Term/Code Not Available 98
Detachment of Device or Device Component 87
Material Integrity Problem 87
Metal Shedding Debris 87
Mechanics Altered 73
Detachment Of Device Component 59
Device Damaged by Another Device 51
Device Operates Differently Than Expected 51

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: 792
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: 502
26
2026: 92

Related Entities for Appliance, Fixation, Spinal Interlaminal

Top Manufacturers

MDT SOFAMOR DANEK PUERTO RICO MFG 2,911
WARSAW ORTHOPEDICS 1,856
MEDTRONIC SOFAMOR DANEK 1,277
SYNTHES USA 457
MEDTRONIC SOFAMOR DANEK USA, INC 438
SYNTHES (USA) 324

Event Locations

7,489 (52.6%)
I 5,586 (39.2%)
HOSPITAL 789 (5.5%)
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%)
OUTDOORS 1 (0.0%)

Compare MDT SOFAMOR DANEK PUERTO RICO MFG vs WARSAW ORTHOPEDICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Appliance, Fixation, Spinal Interlaminal, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (14,243 here).

Single Use Only Blood Lancet With An Integr… 14,056 Tube Tracheostomy And Tube Cuff 14,497 Laparoscope, Gynecologic 14,581 Dressing, Wound, Occlusive 14,583

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 System, Image Processing, Radiological 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.