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2026 data FDA MAUDE openFDA FDA Class II

Methyl Methacrylate For Cranioplasty

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 §882.5300 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Methyl Methacrylate For Cranioplasty LIGHT-BOOK · MAUDE

#966 of 1000 · 403 reports · 1996–2026

  • BOOK 403 reports
  • RANK #966 of 1000
  • DEATH 7 death-typed
  • INJ 220 injury-typed
  • MALF 110 malfunction
  • SPAN 1996–2026
  • PEAK 2010: 59
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Thalamic, Epilepsy, Implanted (0 report gap)

Methyl Methacrylate For Cranioplasty sits #966 of 1000 among tracked device types with 403 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 sit below the device-type norm

Methyl Methacrylate For Cranioplasty carries 27.3% MALFUNCTION-coded reports, 37.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 54.6% corpus 30.3% · above corpus mean (+24.3 pp)
  • MALF 27.3% corpus 64.8% · below corpus mean (-37.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 19% of coded problems · Lead manufacturer WRIGHTS LANE SYNTHES USA PRODUCTS LLC accounts for 52% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Methyl Methacrylate For Cranioplasty in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Methyl Methacrylate For Cranioplasty carries 403 MAUDE reports, ranked #966 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 220 (54.6%)
Malfunction 110 (27.3%)
Other 61 (15.1%)
Death 7 (1.7%)
5 (1.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

171 (40.9%)
Required Intervention 154 (36.8%)
Other 51 (12.2%)
Hospitalization 18 (4.3%)
R 10 (2.4%)
Death 7 (1.7%)
O 3 (0.7%)
S 2 (0.5%)
Congenital Anomaly 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 67
Insufficient Device Problem Information 52
Explanted 31
Device Operates Differently Than Expected 27
Failure To Adhere Or Bond 22
Unknown (for use when the device problem is not known) 17
Break 16
Migration or Expulsion of Device 13
Device remains implanted 12
Other (for use when an appropriate device code cannot be identified) 12
Loss of or Failure to Bond 11
Material Disintegration 11
Crack 10
Appropriate Device Problem Term/Code Not Available 8
Fracture 8
Material Fragmentation 8
Device Expiration Issue 7
Device Appears to Trigger Rejection 6
Device Contamination with Chemical or Other Material 6
Reaction 6

Yearly Trend

96
1996: 5
97
1997: 2
98
1998: 9
99
1999: 3
00
2000: 7
01
2001: 2
02
2002: 8
03
2003: 12
04
2004: 11
05
2005: 13
06
2006: 8
07
2007: 8
08
2008: 10
09
2009: 22
10
2010: 59
11
2011: 31
12
2012: 28
13
2013: 18
14
2014: 19
15
2015: 13
16
2016: 17
17
2017: 16
18
2018: 9
19
2019: 9
20
2020: 31
21
2021: 14
22
2022: 3
23
2023: 2
24
2024: 10
25
2025: 1
26
2026: 3

Reports fell to 1 in 2025, down from an average of 6 in the two years before.

Related Entities for Methyl Methacrylate For Cranioplasty

Top Manufacturers

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 37
SYNTHES (USA) 13
SYNTHES MONUMENT 13
BIOMET MICROFIXATION 8

Event Locations

276 (68.5%)
I 97 (24.1%)
HOSPITAL 22 (5.5%)
OTHER 4 (1.0%)
HOME 1 (0.2%)
INVALID DATA 1 (0.2%)
NO INFORMATION 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare WRIGHTS LANE SYNTHES USA PRODUCTS LLC vs SYNTHES (USA) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Methyl Methacrylate For Cranioplasty: 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 (403 here).

Stimulator, Thalamic, Epilepsy, Implanted 403 Camera, Scintillation 404 Coagulator-Cutter, Endoscopic, Unipolar 404 Enteral Specific Transition Connectors 402

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Methyl Methacrylate For Cranioplasty 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 Methyl Methacrylate For Cranioplasty; 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.