Unit, Operative Dental
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 §872.6640 (Dental panel).
FDA MAUDE casebook
openFDA event book Unit, Operative Dental LIGHT-BOOK · MAUDE
#586 of 1000 · 1,407 reports · 1996–2026
- BOOK 1,407 reports
- RANK #586 of 1000
- DEATH 0 death-typed
- INJ 34 injury-typed
- MALF 1,370 malfunction
- SPAN 1996–2026
- PEAK 2015: 452
- PHOTO Sacroiliac Joint Fixa…
Nearest event-volume peer: Sacroiliac Joint Fixation (1 report gap)
Unit, Operative Dental sits #586 of 1000 among tracked device types with 1,407 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 run above the device-type norm
Unit, Operative Dental carries 97.4% MALFUNCTION-coded reports, 32.5pp 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 2.4% corpus 30.3% · below corpus mean (-27.9 pp)
- MALF 97.4% corpus 64.8% · above corpus mean (+32.5 pp)
Lead product-problem code Overheating of Device is 25% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 83% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Unit, Operative Dental in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- External Mand…
External Mandibular Fixator And/Or Distractor
1,416 reports
- Locator
Locator, Root Apex
1,412 reports
- Unit (this)
Unit, Operative Dental
1,407 reports
- Sacroiliac Jo…
Sacroiliac Joint Fixation
1,406 reports
- Lens
Lens, Intraocular, Accommodative
1,402 reports
- Dressing
Dressing, Wound, Hydrophilic
1,397 reports
What this shows Unit, Operative Dental carries 1,407 MAUDE reports, ranked #586 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (47) held close to the prior two-year average of 53.
Related Entities for Unit, Operative Dental
Top Manufacturers
Event Locations
Compare STRYKER INSTRUMENTS-KALAMAZOO vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →
Nationwide devices with a comparable report-volume footprint
Unit, Operative Dental 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 (1,407 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Unit, Operative Dental 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 Unit, Operative Dental; 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.