Plate, Cranioplasty, Preformed, Non-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 §882.5330 (Neurology panel).
FDA MAUDE casebook
openFDA event book Plate LIGHT-BOOK · MAUDE
#719 of 1000 · 824 reports · 1997–2026
- BOOK 824 reports
- RANK #719 of 1000
- DEATH 2 death-typed
- INJ 555 injury-typed
- MALF 231 malfunction
- SPAN 1997–2026
- PEAK 2017: 74
- PHOTO Catheter
Nearest event-volume peer: Catheter, Hemodialysis, Triple Lumen, Non-Implanted (1 report gap)
Plate, Cranioplasty, Preformed, Non-Alterable sits #719 of 1000 among tracked device types with 824 MAUDE reports spanning 1997–2026. 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
Plate carries 67.4% INJURY-coded reports, 37.1pp above 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 67.4% corpus 30.3% · above corpus mean (+37.1 pp)
- MALF 28.0% corpus 64.8% · below corpus mean (-36.8 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 30% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Plate in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Device
Device, Warming. Blood And Plasma
828 reports
- Catheter
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
825 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polyester
825 reports
- Plate (this)
Plate, Cranioplasty, Preformed, Non-Alterable
824 reports
- Device
Device, Fixation, Tracheal Tube
822 reports
- Instrument
Instrument, Compression
822 reports
What this shows Plate, Cranioplasty, Preformed, Non-Alterable carries 824 MAUDE reports, ranked #719 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 (24) held close to the prior two-year average of 34.
Related Entities for Plate, Cranioplasty, Preformed, Non-Alterable
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Plate: 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 (824 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Plate 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; 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.