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2026 data FDA MAUDE openFDA FDA Class I

Tap, Bone

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §888.4540 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Tap, Bone LIGHT-BOOK · MAUDE

#604 of 1000 · 1,305 reports · 1992–2026

  • BOOK 1,305 reports
  • RANK #604 of 1000
  • DEATH 0 death-typed
  • INJ 157 injury-typed
  • MALF 1,132 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 125
  • PHOTO Continuous Measuremen…

Nearest event-volume peer: Continuous Measurement Thermometer (2 report gap)

Tap, Bone sits #604 of 1000 among tracked device types with 1,305 MAUDE reports spanning 1992–2026. 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 run above the device-type norm

Tap, Bone carries 86.7% MALFUNCTION-coded reports, 21.9pp above 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 12.0% corpus 30.3% · below corpus mean (-18.3 pp)
  • MALF 86.7% corpus 64.8% · above corpus mean (+21.9 pp)

Lead product-problem code Break is 51% of coded problems · Lead manufacturer WRIGHTS LANE SYNTHES USA PRODUCTS LLC accounts for 35% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Tap, Bone in the event-volume neighbourhood

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

reports

What this shows Tap, Bone carries 1,305 MAUDE reports, ranked #604 of 1000.

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

Event Types

Malfunction 1,132 (86.7%)
Injury 157 (12.0%)
Other 11 (0.8%)
5 (0.4%)

Patient Outcomes

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

1,048 (80.8%)
Other 122 (9.4%)
Required Intervention 94 (7.2%)
Hospitalization 15 (1.2%)
R 13 (1.0%)
O 3 (0.2%)
S 2 (0.2%)

Top Product Problems

Break 692
Device-Device Incompatibility 211
Fracture 80
Contamination /Decontamination Problem 71
Material Deformation 47
Detachment Of Device Component 31
Material Fragmentation 29
Failure to Cut 24
Crack 19
Entrapment of Device 18
Device, or device fragments remain in patient 17
Difficult to Remove 17
Tip breakage 15
Device Operates Differently Than Expected 14
Material Separation 14
Mechanical Jam 14
Adverse Event Without Identified Device or Use Problem 13
Detachment of Device or Device Component 12
Material Twisted/Bent 11
Appropriate Device Problem Term/Code Not Available 10

Yearly Trend

92
1992: 1
93
1993: 3
96
1996: 6
97
1997: 8
98
1998: 4
99
1999: 2
00
2000: 2
01
2001: 1
03
2003: 1
04
2004: 7
05
2005: 4
06
2006: 5
07
2007: 11
08
2008: 7
09
2009: 37
10
2010: 38
11
2011: 38
12
2012: 17
13
2013: 60
14
2014: 43
15
2015: 66
16
2016: 72
17
2017: 43
18
2018: 52
19
2019: 125
20
2020: 85
21
2021: 91
22
2022: 91
23
2023: 84
24
2024: 84
25
2025: 103
26
2026: 114

Reports in 2025 (103) held close to the prior two-year average of 84.

Related Entities for Tap, Bone

Top Manufacturers

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 258
SYNTHES GMBH 243
DEPUY SPINE INC 75
OBERDORF SYNTHES PRODUKTIONS GMBH 48
SYNTHES MONUMENT 38
DEPUY SYNTHES SPINE 34
ZIMMER BIOMET, INC. 34

Event Locations

747 (57.2%)
I 460 (35.2%)
HOSPITAL 85 (6.5%)
NO INFORMATION 6 (0.5%)
AMBULATORY SURGICAL FACILITY 4 (0.3%)
INVALID DATA 2 (0.2%)
OTHER 1 (0.1%)

Compare WRIGHTS LANE SYNTHES USA PRODUCTS LLC vs SYNTHES GMBH →

Nationwide devices with a comparable report-volume footprint

Tap, Bone 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 (1,305 here).

Continuous Measurement Thermometer 1,303 Needle, Conduction, Anesthetic 1,308 Endoscopic Access Overtube 1,312 Disinfector, Medical Devices 1,315

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 Tap, Bone 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 Tap, Bone; 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.