THINFLAP SYSTEM 91-6704Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841036134808), received between Mar 6, 2019 and Nov 19, 2020 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K121589, K121624, K953385); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 ↗
• 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 ↗
• InjuryJul 25, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829445 ↗
• MalfunctionJun 14, 2019Device Slipped; Device Slipped

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700331 ↗
• MalfunctionApr 17, 2019Misconnection; Misconnection

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8523850 ↗
• InjuryMar 6, 2019Adverse 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: Unspecified Infection

  MAUDE report 8396576 ↗
• InjuryMar 6, 2019Adverse 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: Bacterial Infection

  MAUDE report 8394281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121589, K121624, K953385. One submission often covers many models, so check the product and lot details in each record.

• Z-1220-2017 · Jan 10, 2017 · Terminated
  1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0835-2012 · Nov 8, 2010 · Terminated
  Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS
• Z-0836-2012 · Nov 8, 2010 · Terminated
  Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE T
• Z-2385-2011 · Jul 28, 2010 · Terminated
  ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBL
• Z-2873-2011 · May 17, 2010 · Terminated
  "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSON
• Z-1286-2012 · Apr 26, 2010 · Terminated
  Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-L
• Z-2206-2010 · Mar 17, 2010 · Terminated
  BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPO
• Z-1151-2010 · Oct 6, 2009 · Terminated
  BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MI
• Z-1943-2010 · Oct 5, 2009 · Terminated
  BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with