"1.5MM" SYSTEMRecalls & reported problems across all models

We found 35 models of "1.5MM" SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2019 and Jan 22, 2026 — classified as 88 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Fracture” (146 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 "1.5MM" SYSTEM problems

"1.5MM" SYSTEM models

35 models, most reported first. Each model has its own page with its reports, recalls and device details.

• "1.5MM" SYSTEM 01-7144

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  32 reports
• "1.5MM" SYSTEM 95-6104

  FASTENER, PLATE, CRANIOPLASTY
  30 reports
• "1.5MM" SYSTEM 95-1505

  COVER, BURR HOLE
  23 reports
• "1.5MM" SYSTEM 91-6105

  COVER, BURR HOLE
  20 reports
• "1.5MM" SYSTEM 95-6105

  FASTENER, PLATE, CRANIOPLASTY
  16 reports
• "1.5MM" SYSTEM 01-7148

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  13 reports
• 1.5MM SYSTEM 50-1010

  MOTOR, SURGICAL INSTRUMENT, AC-POWERED
  13 reports
• "1.5MM" SYSTEM 91-6104

  Plate, cranioplasty, preformed, alterable
  9 reports
• "1.5MM" SYSTEM 91-6106

  COVER, BURR HOLE
  7 reports
• "1.5MM" SYSTEM 01-6482

  PLATE, BONE
  6 reports
• 1.5MM SYSTEM 91-6105X-50

  COVER, BURR HOLE
  6 reports
• 1.5MM SYSTEM 91-6104-50

  FASTENER, PLATE, CRANIOPLASTY
  6 reports
• "1.5MM" SYSTEM 01-7142

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  5 reports
• 1.5MM SYSTEM 91-6105X

  FASTENER, PLATE, CRANIOPLASTY
  5 reports
• 1.5MM SYSTEM 95-6105X

  Plate, cranioplasty, preformed, alterable
  4 reports
• "1.5MM" SYSTEM 01-6480

  PLATE, BONE
  3 reports
• 1.5MM SYSTEM 01-7114

  COVER, BURR HOLE
  2 reports
• "1.5MM" SYSTEM 91-1509

  PLATE, BONE
  2 reports
• "1.5MM" SYSTEM 91-1513

  PLATE, BONE
  2 reports
• "1.5MM" SYSTEM 91-1515

  PLATE, BONE
  2 reports
• "1.5MM" SYSTEM 95-1504

  Plate, cranioplasty, preformed, alterable
  2 reports
• "1.5MM" SYSTEM 95-6106

  Plate, cranioplasty, preformed, alterable
  2 reports
• "1.5MM" SYSTEM 95-6107

  COVER, BURR HOLE
  2 reports
• 1.5MM SYSTEM 01-7048

  PLATE, BONE
  1 report
• "1.5MM" SYSTEM 01-7171

  PLATE, BONE
  1 report
• 1.5MM SYSTEM 01-7309

  COVER, BURR HOLE
  1 report
• 1.5MM SYSTEM 01-7347

  COVER, BURR HOLE
  1 report
• "1.5MM" SYSTEM 91-1511

  PLATE, BONE
  1 report
• "1.5MM" SYSTEM 91-1805

  FASTENER, PLATE, CRANIOPLASTY
  1 report
• "1.5MM" SYSTEM 91-6103

  PLATE, BONE
  1 report
• "1.5MM" SYSTEM 95-1508

  PLATE, BONE
  1 report
• "1.5MM" SYSTEM 95-1509

  PLATE, BONE
  1 report
• "1.5MM" SYSTEM 95-1805

  PLATE, BONE
  1 report
• 1.5MM SYSTEM 15-1725

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 report
• 1.5MM SYSTEM 01-8679

  FASTENER, PLATE, CRANIOPLASTY
  1 report

Recent "1.5MM" SYSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INSPECTION AT THE DISTRIBUTORSHIP, IT WAS FOUND THAT THE INNER PACKAGING HAD A HAIR-LIKE SUBSTANCE WITHIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152457 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 7, 2025Fracture; Fracture

  IT IS REPORTED THAT WHILE THE SURGEON WAS USING THE DRILL BIT TO DRILL THROUGH THE MUCOSA AND BONE TO PLACE 1.5MM SCREWS FOR IMF FIXATION, THE DRILL BIT FRACTURED. THIS ALSO HAPPENED WITH ANOTHER DRILL BIT. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412840 ↗
• MalfunctionJun 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, A DRILL TIP FRACTURED. THE BROKEN TIP WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING BACKUP INSTRUMENTATION. THE SURGICAL TECHNIQUE WAS FOLLOWED. NO ADDITIONAL HARM TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167410 ↗
• InjuryMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22106225 ↗
• InjuryMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22106216 ↗
• 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 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DRILL WAS FRACTURED DURING USAGE BUT ALL FRAGMENTS WERE RETRIEVED. 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 21529334 ↗
• MalfunctionNov 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT A DRILL BROKE DURING USE. THE FRAGMENTS WERE RECOVERED. NO FRAGMENTS REMAIN IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662418 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING A PROCEDURE. ALL DEBRIS/FRAGMENTS WERE RECOVERED. 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 20612258 ↗

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