OsteoMed 218-1604Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845694034258), received between Jun 9, 2022 and Feb 12, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 31, 2023Open, Classified

   Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

   Z-2107-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN EMAIL FROM THE PATIENT, "I HAD SURGERY USING YOUR PARTS, RECALL Z-2107-2023. MY SKULL PLATELETS HAVE BEEN MOVING AROUND IN PIECES FOR YEARS AND IF I HAD KNOWN TO LET MY DOCTOR KNOW I COULD HAVE GOTTEN THEM REPLACED. I THOUGHT THAT IT WAS NORMAL FOR THEM TO NOT STICK TOGETHER. I'VE MADE AN APPOINTMENT WITH THE SURGEON TO GET THEM REPLACED AND I'M LOOKING INTO WHAT I CAN DO TO GET COMPENSATED FOR THE PAIN, MIGRAINES AND SEIZURES THAT I'VE BEEN HAVING DUE TO THIS."

  Patient problems: Pain

  MAUDE report 24328863 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW SLIPPED RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE LIFTED UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE (5) 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00032, 2207754-2022-00033, 2207754-2022-00034, AND 2207754-2022-00035 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640798 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW "SLIPPED" RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE "LIFTED" UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00031, 2207754-2022-00032, 2207754-2022-00033, AND 2207754-2022-00034 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640757 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW "SLIPPED" RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE "LIFTED" UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE (5) 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00031, 2207754-2022-00033, 2207754-2022-00034, AND 2207754-2022-00035 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640754 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW "SLIPPED" RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE "LIFTED" UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE (5) 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00031, 2207754-2022-00032, 2207754-2022-00033, AND 2207754-2022-00035 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640744 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW "SLIPPED" RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE "LIFTED" UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00031, 2207754-2022-00032, 2207754-2022-00034, AND 2207754-2022-00035 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640739 ↗