THINFLAP SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 3 models of THINFLAP SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2019 and Nov 19, 2020 — classified as 9 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported THINFLAP SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Device-Device Incompatibility5
- Fracture4
- Dull, Blunt3
- Material Deformation3
- Device Slipped1
- Misconnection1
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient13
- Unspecified Infection3
- Bacterial Infection2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Information1
- No Patient Involvement1
THINFLAP SYSTEM models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- THINFLAP SYSTEM 91-6704Plate, cranioplasty, preformed, alterable19 reports
- THINFLAP SYSTEM 19-1040PLATE, BONE3 reports
- THINFLAP SYSTEM 91-6904COVER, BURR HOLE1 report
Recent THINFLAP SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 19, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10869106 ↗MalfunctionJul 21, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10303809 ↗MalfunctionJun 22, 2020Dull, Blunt; Dull, Blunt
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10179934 ↗MalfunctionJun 4, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SCREW THREAD WAS DEFORMED AND COULD NOT BE GRIPPED BY THE DRIVER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10120197 ↗MalfunctionJun 4, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10120194 ↗MalfunctionJun 3, 2020Material Deformation; Material Deformation
IT WAS REPORTED TWO (2) SCREWS WERE STRIPPED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE SCREWS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10115387 ↗MalfunctionMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10033545 ↗InjuryMay 5, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10024931 ↗MalfunctionMay 4, 2020Material Deformation; Material Deformation
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10020557 ↗InjuryFeb 24, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 9746455 ↗MalfunctionJan 21, 2020Dull, Blunt; Dull, Blunt
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9612639 ↗MalfunctionJan 14, 2020No Apparent Adverse Event; No Apparent Adverse Event
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9586563 ↗MalfunctionJan 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9583759 ↗MalfunctionJan 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9583755 ↗MalfunctionSep 6, 2019Dull, Blunt; Dull, Blunt
IT WAS REPORTED THE SELF-DRILLING SCREWS WOULD NOT INSERT WELL INTO THE BONE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8972960 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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