"1.5MM" SYSTEM 95-6104Recalls & reported problems
Biomet Microfixation, Inc · Class 2
Quick summary
This is a Biomet Microfixation 1.5mm System 95-6104 bone fastener, plate and cranioplasty screw set used to hold skull plates in place during head and face surgery. The 30 reports mostly describe screws breaking or deforming while being placed, threads or tips damaging so screws slip or won't advance into bone, and pieces of hardware left in patients. Six reports describe injuries and no deaths. There are no recalls naming this device, and reporting activity is flat, with one report in each of the last two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00841036056650), received between Mar 6, 2019 and Jan 5, 2026 — classified as 6 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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.
Reports received per month
Most reported problems
Device problems
- Fracture14
- Material Deformation6
- Device-Device Incompatibility3
- Difficult to Insert2
- Dull, Blunt2
- Failure to Advance2
- Compatibility Problem1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient12
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient5
- No Consequences Or Impact To Patient5
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2026Fracture
IT WAS REPORTED THAT A SCREW FRACTURED WHILE PRE-PLACING SCREWS ON THE SKULL DURING A CRANIOMAXILLOFACIAL PROCEDURE, AND A NEW SCREW WAS IMMEDIATELY USED AS A REPLACEMENT. THE BREAKAGE WAS NOTED INTRA-OPERATIVELY DURING SETUP FOR CRANIAL FIXATION, AND THE REPORTER CONFIRMED NO FOREIGN BODIES WERE RETAINED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23957243 ↗MalfunctionOct 15, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT A PACK OF SCREWS WERE UNABLE TO BE FIXATED PROPERLY DURING A CRANIAL PROCEDURE AND REPLACEMENT SCREWS OF THE SAME MODEL WERE USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299387 ↗MalfunctionOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SCREW FRACTURED DURING THE IMPLANTATION. THERE WAS 20-MINUTE DELAY. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515394 ↗MalfunctionFeb 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278246 ↗MalfunctionJan 25, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREAD OF SCREW WAS DAMAGED RESULTING IN THE SCREW SLIPPING ON THE SURFACE OF THE BONE. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16239798 ↗MalfunctionJan 19, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF SCREW WAS FRACTURED DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13288584 ↗MalfunctionJan 18, 2022Fracture; Fracture
IT WAS REPORTED THE SCREW WAS BROKEN WHEN FIXING. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13283175 ↗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 11640680 ↗MalfunctionNov 4, 2020Fracture; Fracture
IT WAS REPORTED THE SCREWS FRACTURED DURING INSERTION. THE TIPS OF THE SCREWS WERE FOUND DURING THE OPERATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10785908 ↗MalfunctionNov 4, 2020Fracture; Fracture
IT WAS REPORTED THE SCREWS FRACTURED DURING INSERTION. THE TIPS OF THE SCREWS WERE FOUND DURING THE OPERATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10785892 ↗MalfunctionOct 15, 2020Material Deformation; Material Deformation
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10686759 ↗MalfunctionOct 15, 2020Material Deformation; Material Deformation
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10683177 ↗InjuryAug 8, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10383019 ↗MalfunctionAug 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10356509 ↗MalfunctionJun 18, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SCREW COULD NOT BE RETAINED BY THE DRIVER DURING A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10167099 ↗MalfunctionMay 5, 2020Material Deformation; Material Deformation
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10025152 ↗MalfunctionApr 10, 2020Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE SCREWS WOULD NOT ENTER THE BONE DURING A CRANIAL PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9949928 ↗MalfunctionMar 30, 2020Device-Device Incompatibility; Device-Device Incompatibility
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9900444 ↗InjuryMar 10, 2020Fracture; Fracture
IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT A SCREW, THE SCREW FRACTURED HALFWAY INTO THE BONE. THE FRACTURED PORTION OF THE SCREW WAS NOT REMOVED AND REMAINED IN THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 9813130 ↗MalfunctionDec 26, 2019Compatibility Problem; Compatibility Problem
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9520498 ↗MalfunctionDec 26, 2019Device-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 9520486 ↗MalfunctionDec 6, 2019Material 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 9429195 ↗MalfunctionDec 6, 2019Material 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 9428472 ↗InjuryDec 5, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 9418089 ↗MalfunctionDec 3, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9405605 ↗
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 · Terminated1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Z-0137-2016 · Aug 6, 2015 · TerminatedThinflap System Case The cases hold surgical instrumentation in place during handling and storage.
- Z-0136-2016 · Aug 6, 2015 · TerminatedNeuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
- Z-0835-2012 · Nov 8, 2010 · TerminatedPackage 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 · TerminatedPackage 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 · TerminatedProduct 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 · TerminatedBIOMET 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 · TerminatedBIOMET 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 · TerminatedBIOMET 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
Other FASTENER, PLATE, CRANIOPLASTY devices
- RapidSorb 530.553.01SSynthes GmbH · FASTENER, PLATE, CRANIOPLASTY1 recall0 reports
- "1.5MM" SYSTEM 95-6105Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY16 reports
- UNIVERSAL NEURO 3 56-15904Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY7 reports
- 1.5MM SYSTEM 91-6104-50Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY6 reports
- 1.5MM SYSTEM 91-6105XBiomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY5 reports
- Universal Neuro 3 56-15934Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY4 reports
- Universal Neuro 3 56-15034Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY2 reports
- Universal Neuro 3 56-15935Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.