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2020 data FDA MAUDE openFDA FDA Class II

Screw, Fixation, Bone, Non-Spinal, Metallic

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 §888.3040 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Screw, Fixation, Bone, Non-Spinal, Metallic LIGHT-BOOK · MAUDE

#591 of 1000 · 1,380 reports · 2001–2020

  • BOOK 1,380 reports
  • RANK #591 of 1000
  • DEATH 2 death-typed
  • INJ 1,358 injury-typed
  • MALF 18 malfunction
  • SPAN 2001–2020
  • PEAK 2013: 364
  • PHOTO Catheter For Crossing…

Nearest event-volume peer: Catheter For Crossing Total Occlusions (10 report gap)

Screw, Fixation, Bone, Non-Spinal, Metallic sits #591 of 1000 among tracked device types with 1,380 MAUDE reports spanning 2001–2020. 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

Screw, Fixation, Bone, Non-Spinal, Metallic carries 98.4% INJURY-coded reports, 68.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 98.4% corpus 30.3% · above corpus mean (+68.1 pp)
  • MALF 1.3% corpus 64.8% · below corpus mean (-63.5 pp)

Lead product-problem code Insufficient Device Problem Information is 31% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 64% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Screw, Fixation, Bone, Non-Spinal, Metallic in the event-volume neighbourhood

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

reports

What this shows Screw, Fixation, Bone, Non-Spinal, Metallic carries 1,380 MAUDE reports, ranked #591 of 1000.

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

Event Types

Injury 1,358 (98.4%)
Malfunction 18 (1.3%)
2 (0.1%)
Death 2 (0.1%)

Patient Outcomes

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

Required Intervention 1,245 (89.0%)
Other 84 (6.0%)
32 (2.3%)
R 19 (1.4%)
Death 14 (1.0%)
Hospitalization 5 (0.4%)

Top Product Problems

Insufficient Device Problem Information 582
Loss of Osseointegration 366
Adverse Event Without Identified Device or Use Problem 165
Implant, removal of 115
Loose or Intermittent Connection 97
Osseointegration Problem 85
Loss of or Failure to Bond 82
Loose 57
Malposition of Device 46
Appropriate Device Problem Term/Code Not Available 39
Metal Shedding Debris 38
Unknown (for use when the device problem is not known) 36
Break 34
Device Dislodged or Dislocated 28
Migration or Expulsion of Device 26
Fracture 18
Other (for use when an appropriate device code cannot be identified) 17
Explanted 11
Noise, Audible 11
Dislocated 6

Yearly Trend

01
2001: 4
02
2002: 1
03
2003: 1
05
2005: 1
06
2006: 3
07
2007: 5
08
2008: 45
09
2009: 72
10
2010: 111
11
2011: 165
12
2012: 189
13
2013: 364
14
2014: 326
15
2015: 48
16
2016: 4
17
2017: 4
18
2018: 8
19
2019: 22
20
2020: 7

Reports rose to 22 in 2019, up from an average of 6 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Screw, Fixation, Bone, Non-Spinal, Metallic

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 304
DEPUY ORTHOPAEDICS, INC. 84
DEPUY ORTHOPAEDICS, INC. 1818910 47
DEPUY WARSAW 42

Event Locations

993 (72.0%)
I 378 (27.4%)
HOSPITAL 4 (0.3%)
NO INFORMATION 4 (0.3%)
HOME 1 (0.1%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Screw, Fixation, Bone, Non-Spinal, Metallic: 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 (1,380 here).

Catheter For Crossing Total Occlusions 1,370 Dressing, Wound, Hydrophilic 1,397 Dura Substitute 1,397 Lens, Intraocular, Accommodative 1,402

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Screw, Fixation, Bone, Non-Spinal, Metallic 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 Screw, Fixation, Bone, Non-Spinal, Metallic; 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.