Screw, Fixation, 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 II (moderate risk, special controls required), regulated under 21 CFR §888.3040 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Screw, Fixation, Bone MID-BOOK · MAUDE
#61 of 1000 · 58,626 reports · 1992–2026
- BOOK 58,626 reports
- RANK #61 of 1000
- DEATH 75 death-typed
- INJ 39,416 injury-typed
- MALF 18,053 malfunction
- SPAN 1992–2026
- PEAK 2019: 5,464
- PHOTO Implantable Pacemaker…
Nearest event-volume peer: Implantable Pacemaker Pulse-Generator (857 report gap)
Screw, Fixation, Bone sits #61 of 1000 among tracked device types with 58,626 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 →
Injury-coded reports run above the device-type norm
Screw, Fixation, Bone carries 67.2% INJURY-coded reports, 36.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 67.2% corpus 30.3% · above corpus mean (+36.9 pp)
- MALF 30.8% corpus 64.8% · below corpus mean (-34.0 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 27% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Screw, Fixation, Bone in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Endoscopic Vi…
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
61,453 reports
- Screw (this)
Screw, Fixation, Bone
58,626 reports
- Implantable P…
Implantable Pacemaker Pulse-Generator
57,769 reports
- Suture
Suture, Absorbable, Synthetic, Polyglycolic Acid
56,265 reports
- Pacemaker/Icd…
Pacemaker/Icd/Crt Non-Implanted Components
55,908 reports
- Stimulator
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
52,959 reports
What this shows Screw, Fixation, Bone carries 58,626 MAUDE reports, ranked #61 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 (2,930) held close to the prior two-year average of 3,646.
Related Entities for Screw, Fixation, Bone
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Screw, Fixation, Bone: 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 (58,626 here).
Similar death-typed counts
Nearest other device types by death-typed report count (75 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Screw, Fixation, 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 Screw, Fixation, 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.