"1.5MM" SYSTEM 95-6105Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00841036056667), received between Mar 20, 2019 and Jul 22, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, FIVE SCREWS FRACTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED USING ALTERNATE SCREWS. NO FRAGMENTS WERE RETAINED, AND THERE WAS NO REPORTED PATIENT HARM OR CONTRIBUTING CONDITIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565676 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, FIVE SCREWS FRACTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED USING ALTERNATE SCREWS. NO FRAGMENTS WERE RETAINED, AND THERE WAS NO REPORTED PATIENT HARM OR CONTRIBUTING CONDITIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563774 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, FIVE SCREWS FRACTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED USING ALTERNATE SCREWS. NO FRAGMENTS WERE RETAINED, AND THERE WAS NO REPORTED PATIENT HARM OR CONTRIBUTING CONDITIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563765 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, FIVE SCREWS FRACTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED USING ALTERNATE SCREWS. NO FRAGMENTS WERE RETAINED, AND THERE WAS NO REPORTED PATIENT HARM OR CONTRIBUTING CONDITIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563763 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, FIVE SCREWS FRACTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED USING ALTERNATE SCREWS. NO FRAGMENTS WERE RETAINED, AND THERE WAS NO REPORTED PATIENT HARM OR CONTRIBUTING CONDITIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619392 ↗
• MalfunctionOct 20, 2021Fracture; Break; Entrapment of Device; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669675 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640750 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640738 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640735 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

  IT WAS REPORTED, THAT THE IMPLANT BROKE DURING A SURGERY THAT OCCURRED APPROXIMATELY TWO (2) YEARS AND FIVE (5) MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640676 ↗
• MalfunctionApr 7, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629341 ↗
• MalfunctionApr 7, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629336 ↗
• MalfunctionOct 15, 2020Fracture; Fracture

  IT WAS REPORTED A SCREW HEAD BROKE DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10686788 ↗
• InjuryMar 12, 2020Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 9825628 ↗
• InjuryMar 2, 2020Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 9775044 ↗
• InjuryMar 20, 2019Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8437870 ↗

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