MatrixNEURO 04.503.104.20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20887587018345), received between Dec 21, 2016 and Jul 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K042365, K123723); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATES, THE SURGEON ENCOUNTERED SCREW BREAKAGE UPON INSERTION OF THE MATRIX NEURO SCREWS IN QUESTION. THE SURGEON MENTIONED THIS AFTER AN INTRAOPERATIVE SCREW BREAKAGE ON (B)(6) 2023. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS AN INTRAOPERATIVE SCREW BREAKAGE ON (B)(6), 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369892 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE ON (B)(6) 2023, THE SURGEON STATED THAT THE SCREW HEAD BROKE FROM THE REST OF THE SCREW WHILE BEING INSERTED, AND THE SCREW WAS ONLY PARTIALLY INSERTED INTO THE BONE WHEN THE SCREW HEAD BROKE OFF. THE SURGEON ALSO MENTIONED THAT THIS HAS HAPPENED MULTIPLE TIMES IN THE PAST WITH THE SAME SCREWS. THE PATIENT WAS NOT ADVERSELY AFFECTED, AND THERE WAS NO SURGICAL DELAY. THE SCREW THREADS WERE REMOVED FROM THE BONE, AND A NEW PLATE WAS PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS STABLE. THIS REPORT INVOLVES ONE TI MATRIXNEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE ALLEGATION THAT THE ISSUE HAS HAPPENED PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369853 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE HEADS OF TWO (2) MATRIXNEURO SCREWS BROKE OFF DURING A SYNTHETIC CRANIOPLASTY PROCEDURE ON (B)(6), 2017. THE SURGEON WAS INSERTING THE SCREWS INTO A PATIENT SPECIFIC PEEK IMPLANT (PSI) WHEN THE TIPS OF TWO OF THE SCREWS BROKE OFF. FRAGMENTS WERE GENERATED IN THE PATIENT BUT WERE ALL REMOVED, EXCEPT FOR THE TIP OF ONE OF THE SCREWS THAT REMAINED IN THE IMPLANT. THE PIECE THAT REMAINED WAS BURRED DOWN UNTIL IT WAS FLUSH WITH THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THERE WAS NO REPORTED SURGICAL DELAY. THIS IS REPORT 2 OF 2 FOR (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122058 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE HEADS OF TWO (2) MATRIXNEURO SCREWS BROKE OFF DURING A SYNTHETIC CRANIOPLASTY PROCEDURE ON (B)(6) 2017. THE SURGEON WAS INSERTING THE SCREWS INTO A PATIENT SPECIFIC PEEK IMPLANT (PSI) WHEN THE TIPS OF TWO OF THE SCREWS BROKE OFF. FRAGMENTS WERE GENERATED IN THE PATIENT BUT WERE ALL REMOVED, EXCEPT FOR THE TIP OF ONE OF THE SCREWS THAT REMAINED IN THE IMPLANT. THE PIECE THAT REMAINED WAS BURRED DOWN UNTIL IT WAS FLUSH WITH THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THERE WAS NO REPORTED SURGICAL DELAY. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122007 ↗
• MalfunctionDec 21, 2016Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING IMPLANTATION THE HEAD OF A SCREW FROM A MATRIX NEURO STERILE KIT BROKE. THE SURGERY WAS NOT PROLONGED. THERE WAS NO PATIENT HARM AND ALL BROKEN OFF PIECES WERE REMOVED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6193085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042365, K123723. One submission often covers many models, so check the product and lot details in each record.

• Z-2698-2020 · Jun 18, 2020 · Terminated
  MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedur