"1.5MM" SYSTEM 91-6105Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00841036053741), received between Jul 5, 2019 and Oct 16, 2024 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT 3 SCREWS WERE FRACTURED DURING PLACEMENT OF THE BONE FLAP. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461925 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREWS FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ALTERNATIVE DEVICES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461748 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREWS FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ALTERNATIVE DEVICES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461695 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT 2 SCREWS WERE FRACTURED DURING PLACEMENT OF THE BONE FLAP. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461693 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT 2 SCREWS WERE FRACTURED DURING THE PLACEMENT OF BONE FLAP. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461684 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT 3 SCREWS WERE FRACTURED DURING PLACEMENT OF THE BONE FLAP. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461654 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREWS FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ALTERNATIVE DEVICES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461579 ↗
• MalfunctionFeb 6, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650561 ↗
• InjuryMar 21, 2023Fracture; Fracture

  IT IS REPORTED THAT DURING A PROCEDURE WHILE PLACING A TREPHINATION PLATE WITH SCREWS, THAT THREE OF THE SCREWS FRACTURED CREATING THE NEED TO PLACE THE PLATE IN ANOTHER AREA. THERE WAS A SURGICAL DELAY AND THREE FRAGMENTS OF THE SCREWS REMAINED WITHIN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 16584182 ↗
• InjuryMar 21, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16583924 ↗
• InjuryMar 21, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16583915 ↗
• MalfunctionFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578991 ↗
• MalfunctionFeb 22, 2022Material Fragmentation

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578952 ↗
• MalfunctionFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578944 ↗
• MalfunctionFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578939 ↗
• MalfunctionAug 16, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329095 ↗
• MalfunctionAug 16, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329087 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bruise/Contusion; Fluid Discharge; Necrosis

  MAUDE report 10508274 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW TIP WAS BROKEN AND THE SURGEON COMPLETED THE PROCEDURE WITH OTHER SCREWS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9940867 ↗
• InjuryJul 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION REGARDING THE RETENTION OF A FOREIGN BODY IN THE PATIENT'S BONE, BUT CONFLICTING RESPONSES WERE RECEIVED. THEREFORE, ZIMMER BIOMET CANNOT DETERMINE IF A FOREIGN BODY WAS RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8765717 ↗

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-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
• 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-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-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