2026 data FDA MAUDE openFDA FDA Class I

Instrument, Compression

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).

FDA MAUDE casebook

openFDA event book Instrument, Compression LIGHT-BOOK · MAUDE

#721 of 1000 · 822 reports · 1992–2026

  • BOOK 822 reports
  • RANK #721 of 1000
  • DEATH 0 death-typed
  • INJ 26 injury-typed
  • MALF 793 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 181
  • PHOTO Device

Nearest event-volume peer: Device, Fixation, Tracheal Tube (0 report gap)

Instrument, Compression sits #721 of 1000 among tracked device types with 822 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

Instrument, Compression carries 96.5% MALFUNCTION-coded reports, 31.6pp 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 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
  • MALF 96.5% corpus 64.8% · above corpus mean (+31.6 pp)

Lead product-problem code Break is 46% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 43% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Instrument, Compression in the event-volume neighbourhood

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

reports

What this shows Instrument, Compression carries 822 MAUDE reports, ranked #721 of 1000.

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

Event Types

Malfunction 793 (96.5%)
Injury 26 (3.2%)
2 (0.2%)
Other 1 (0.1%)

Patient Outcomes

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

761 (94.5%)
Required Intervention 27 (3.4%)
Other 17 (2.1%)

Top Product Problems

Break 410
Device-Device Incompatibility 116
Crack 59
Material Deformation 46
Material Twisted/Bent 45
Naturally Worn 43
Detachment of Device or Device Component 19
Mechanical Jam 19
Entrapment of Device 16
Failure to Cut 15
Fracture 14
Device Slipped 12
Detachment Of Device Component 11
Scratched Material 11
Structural Problem 11
Component Missing 10
Material Fragmentation 10
Residue After Decontamination 10
Appropriate Device Problem Term/Code Not Available 9
Contamination /Decontamination Problem 9

Yearly Trend

92
1992: 1
94
1994: 2
06
2006: 3
08
2008: 1
09
2009: 3
11
2011: 7
12
2012: 5
13
2013: 36
14
2014: 21
15
2015: 8
16
2016: 16
17
2017: 29
18
2018: 21
19
2019: 37
20
2020: 51
21
2021: 88
22
2022: 64
23
2023: 82
24
2024: 83
25
2025: 181
26
2026: 83

Reports rose to 181 in 2025, up from an average of 83 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Instrument, Compression

Event Locations

588 (71.5%)
I 228 (27.7%)
HOSPITAL 5 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare DEPUY IRELAND - 9616671 vs SYNTHES GMBH →

Nationwide devices with a comparable report-volume footprint

Instrument, Compression 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 (822 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Instrument, Compression 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 Instrument, Compression; 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.