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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Finger, Constrained, Polymer

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 §888.3230 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis, Finger, Constrained, Polymer LIGHT-BOOK · MAUDE

#900 of 1000 · 492 reports · 1996–2026

  • BOOK 492 reports
  • RANK #900 of 1000
  • DEATH 0 death-typed
  • INJ 399 injury-typed
  • MALF 54 malfunction
  • SPAN 1996–2026
  • PEAK 2020: 48
  • PHOTO Blood Pressure Cuff

Nearest event-volume peer: Blood Pressure Cuff (0 report gap)

Prosthesis, Finger, Constrained, Polymer sits #900 of 1000 among tracked device types with 492 MAUDE reports spanning 1996–2026. 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 →

Malfunction reports sit below the device-type norm

Prosthesis, Finger, Constrained, Polymer carries 11.0% MALFUNCTION-coded reports, 53.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 81.1% corpus 30.3% · above corpus mean (+50.8 pp)
  • MALF 11.0% corpus 64.8% · below corpus mean (-53.9 pp)

Lead product-problem code Fracture is 22% of coded problems · Lead manufacturer STRYKER GMBH accounts for 47% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Prosthesis, Finger, Constrained, Polymer in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Finger, Constrained, Polymer carries 492 MAUDE reports, ranked #900 of 1000.

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

Event Types

Injury 399 (81.1%)
Malfunction 54 (11.0%)
Other 39 (7.9%)

Patient Outcomes

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

Required Intervention 307 (57.6%)
Other 112 (21.0%)
52 (9.8%)
R 25 (4.7%)
Hospitalization 19 (3.6%)
O 10 (1.9%)
H 6 (1.1%)
S 2 (0.4%)

Top Product Problems

Fracture 134
Adverse Event Without Identified Device or Use Problem 131
Break 106
Explanted 52
Implant, removal of 36
Device Dislodged or Dislocated 22
Insufficient Device Problem Information 15
Naturally Worn 15
Replace 15
Component(s), broken 10
Inadequacy of Device Shape and/or Size 8
Unstable 8
Appropriate Device Problem Term/Code Not Available 7
Dislocated 7
Device Slipped 6
Device remains implanted 6
Device Contamination with Chemical or Other Material 5
Material Deformation 5
Material Fragmentation 5
Material Integrity Problem 4

Yearly Trend

96
1996: 1
97
1997: 3
98
1998: 4
99
1999: 4
00
2000: 13
01
2001: 5
02
2002: 1
03
2003: 8
04
2004: 7
05
2005: 2
06
2006: 6
07
2007: 9
08
2008: 15
09
2009: 35
10
2010: 9
11
2011: 11
12
2012: 25
13
2013: 11
14
2014: 14
15
2015: 18
16
2016: 6
17
2017: 14
18
2018: 11
19
2019: 26
20
2020: 48
21
2021: 45
22
2022: 39
23
2023: 24
24
2024: 29
25
2025: 33
26
2026: 16

Reports in 2025 (33) held close to the prior two-year average of 27.

Related Entities for Prosthesis, Finger, Constrained, Polymer

Top Manufacturers

STRYKER GMBH 154
DEPUY ORTHOPAEDICS, INC. 80
ENCORE MEDICAL L.P. 51
DEPUY ORTHOPAEDICS, INC. 1818910 17
ENCORE MEDICAL L.P 15
DEPUY WARSAW 8

Event Locations

305 (62.0%)
I 146 (29.7%)
HOSPITAL 31 (6.3%)
INVALID DATA 4 (0.8%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
HOME 2 (0.4%)
UNKNOWN 2 (0.4%)

Compare STRYKER GMBH vs DEPUY ORTHOPAEDICS, INC. →

Nationwide devices with a comparable report-volume footprint

Prosthesis, Finger, Constrained, Polymer carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (492 here).

Blood Pressure Cuff 492 Enzyme Linked Immunoabsorption Assay 492 Angiography/Angioplasty Kit 494 Joint, Knee, External Limb Component 494

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Prosthesis, Finger, Constrained, Polymer 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 Prosthesis, Finger, Constrained, Polymer; 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.