Retractor
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 §878.4800 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Retractor LIGHT-BOOK · MAUDE
#546 of 1000 · 1,646 reports · 1993–2026
- BOOK 1,646 reports
- RANK #546 of 1000
- DEATH 4 death-typed
- INJ 312 injury-typed
- MALF 1,252 malfunction
- SPAN 1993–2026
- PEAK 2024: 111
- PHOTO Microfilter
Nearest event-volume peer: Microfilter, Blood Transfusion (2 report gap)
Retractor sits #546 of 1000 among tracked device types with 1,646 MAUDE reports spanning 1993–2026. 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 →
Injury-coded reports sit below the device-type norm
Retractor carries 19.0% INJURY-coded reports, 11.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 19.0% corpus 30.3% · below corpus mean (-11.3 pp)
- MALF 76.1% corpus 64.8% · above corpus mean (+11.2 pp)
Lead product-problem code Break is 43% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 29% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Retractor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Processor
Processor, Tissue, Automated
1,657 reports
- Set
Set, Tubing And Support, Ventilator (W Harness)
1,654 reports
- Microfilter
Microfilter, Blood Transfusion
1,648 reports
- Retractor (this)
Retractor
1,646 reports
- Endoscopic Gu…
Endoscopic Guidewire, Gastroenterology-Urology
1,635 reports
- Cement, Dental
Cement, Dental
1,630 reports
What this shows Retractor carries 1,646 MAUDE reports, ranked #546 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 (107) held close to the prior two-year average of 96.
Related Entities for Retractor
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Retractor: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,646 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Retractor 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 Retractor; 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.