Plate, Cranioplasty, Preformed, Alterable
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 §882.5320 (Neurology panel).
FDA MAUDE casebook
openFDA event book Plate, Cranioplasty, Preformed, Alterable LIGHT-BOOK · MAUDE
#681 of 1000 · 944 reports · 2005–2026
- BOOK 944 reports
- RANK #681 of 1000
- DEATH 0 death-typed
- INJ 197 injury-typed
- MALF 742 malfunction
- SPAN 2005–2026
- PEAK 2025: 243
- PHOTO Catheter Care Tray
Nearest event-volume peer: Catheter Care Tray (0 report gap)
Plate, Cranioplasty, Preformed, Alterable sits #681 of 1000 among tracked device types with 944 MAUDE reports spanning 2005–2026. 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
Plate, Cranioplasty, Preformed, Alterable carries 78.6% MALFUNCTION-coded reports, 13.8pp 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 20.9% corpus 30.3% · below corpus mean (-9.4 pp)
- MALF 78.6% corpus 64.8% · above corpus mean (+13.8 pp)
Lead product-problem code Break is 51% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 78% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .
Plate, Cranioplasty, Preformed, Alterable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Plate (this)
Plate, Cranioplasty, Preformed, Alterable
944 reports
- Catheter Care…
Catheter Care Tray
944 reports
- Resectoscope
Resectoscope
940 reports
- Suture
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
936 reports
- Absorbable Co…
Absorbable Coronary Drug-Eluting Stent
929 reports
- Bed, Manual
Bed, Manual
928 reports
What this shows Plate, Cranioplasty, Preformed, Alterable carries 944 MAUDE reports, ranked #681 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 rose to 243 in 2025, up from an average of 111 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Plate, Cranioplasty, Preformed, Alterable
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Plate, Cranioplasty, Preformed, Alterable 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 (944 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 Plate, Cranioplasty, Preformed, Alterable 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 Plate, Cranioplasty, Preformed, Alterable; 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.