PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Probe

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 Probe LIGHT-BOOK · MAUDE

#825 of 1000 · 602 reports · 1992–2026

  • BOOK 602 reports
  • RANK #825 of 1000
  • DEATH 0 death-typed
  • INJ 84 injury-typed
  • MALF 510 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 69
  • PHOTO Table, Obstetric

Nearest event-volume peer: Table, Obstetric (And Accessories) (0 report gap)

Probe sits #825 of 1000 among tracked device types with 602 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

Probe carries 84.7% MALFUNCTION-coded reports, 19.9pp 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 14.0% corpus 30.3% · below corpus mean (-16.3 pp)
  • MALF 84.7% corpus 64.8% · above corpus mean (+19.9 pp)

Lead product-problem code Break is 60% of coded problems · Lead manufacturer DEPUY SPINE INC accounts for 43% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Probe in the event-volume neighbourhood

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

reports

What this shows Probe carries 602 MAUDE reports, ranked #825 of 1000.

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

Event Types

Malfunction 510 (84.7%)
Injury 84 (14.0%)
Other 5 (0.8%)
3 (0.5%)

Patient Outcomes

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

472 (78.5%)
Other 85 (14.1%)
Required Intervention 33 (5.5%)
R 4 (0.7%)
Disability 2 (0.3%)
Hospitalization 2 (0.3%)
O 1 (0.2%)
Invalid Data 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 387
Fracture 83
Material Twisted/Bent 42
Bent 23
Material Deformation 21
Entrapment of Device 13
Detachment Of Device Component 10
Device, or device fragments remain in patient 10
Material Fragmentation 9
Tip breakage 9
Material Separation 7
Device-Device Incompatibility 6
Detachment of Device or Device Component 5
Difficult to Remove 5
Material Integrity Problem 4
Component Missing 3
Contamination /Decontamination Problem 3
Crack 3
Defective Device 3
Device Operates Differently Than Expected 3

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 1
95
1995: 1
00
2000: 2
02
2002: 1
03
2003: 1
04
2004: 3
05
2005: 5
06
2006: 3
08
2008: 1
09
2009: 7
10
2010: 10
11
2011: 10
12
2012: 2
13
2013: 13
14
2014: 11
15
2015: 33
16
2016: 44
17
2017: 58
18
2018: 63
19
2019: 69
20
2020: 39
21
2021: 35
22
2022: 41
23
2023: 47
24
2024: 36
25
2025: 37
26
2026: 23

Reports in 2025 (37) held close to the prior two-year average of 42.

Related Entities for Probe

Top Manufacturers

DEPUY SPINE INC 167
ZIMMER BIOMET SPINE INC. 88
DEPUY SYNTHES SPINE 53
MEDTRONIC SOFAMOR DANEK USA, INC 50
SYNTHES GMBH 16
ZIMMER BIOMET SPINE, INC. 14

Event Locations

I 281 (46.7%)
245 (40.7%)
HOSPITAL 67 (11.1%)
NO INFORMATION 7 (1.2%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OTHER 1 (0.2%)

Compare DEPUY SPINE INC vs ZIMMER BIOMET SPINE INC. →

Nationwide devices with a comparable report-volume footprint

Probe 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 (602 here).

Table, Obstetric 602 Device, Anastomotic, Microvascular 601 Suture, Nonabsorbable 601 Neurosurgical Paddie 600

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 Probe 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 Probe; 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.