NA 03.100.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982070869), received between Feb 3, 2021 and Feb 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE BENDING TEMPLATE FOR THE PELVIC FRACTURE. THE BENDING TEMPLATE IN QUESTION BROKE IN THE MIDDLE OF BENDING AND APPLYING IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH R88 TEMPLATE AND PLATE WITHOUT ANY SURGICAL DELAY. ACCORDING TO THE SURGEON, THE BENDING TEMPLATE MIGHT HAVE BEEN OVERUSED AND DETERIORATING. IT WAS CONFIRMED BY THE IMAGE INTENSIFIER THAT THERE WERE NO FRAGMENTS IN THE PATIENT¿S BODY. THE SURGEON ALSO COMMENTED THAT HE DID NOT UNDERSTAND WHY THE TEMPLATE HAS 16 HOLES, BUT THE IMPLANTS ONLY HAVE UP TO 14 HOLES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396304 ↗
• MalfunctionApr 29, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MOMENT THE SPECIALIST MANEUVERS THE TEMPLATE DEVICE TO MOLD IT ONTO THE PATIENT'S BONE, IT EASILY SPLIT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250288 ↗
• MalfunctionFeb 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, WHEN THE SURGEON USED THE TEMPLATE TO MOLD IT WITHOUT MUCH EFFORT, IT IS DIVIDED INTO TWO. THERE WAS NO SURGICAL DELAY AND NO OTHER MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME IS REPORTED AS OKAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-108MM RAD/16H. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273135 ↗