PECA® PS050160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879513126), received between Dec 31, 2025 and Dec 31, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Material Separation; Material Separation

  WE HAVE RECEIVED A REPORT STATING THAT A PATIENT HAD A NOVASTEP SCREW (PECA COMPRESSIVE 4.0 X 60MM-SN/A, LOT NUMBER H0177A) IMPLANTED. DUE TO THE PAIN EXPERIENCED BY THE PATIENT, A VERIFICATION WAS PERFORMED, WHICH LED TO THE DISCOVERY THAT THE IMPLANT HAD BROKEN. A REVISION SURGERY IS PLANNED. NO FURTHER DETAILS HAVE BEEN COMMUNICATED TO US. MDR REPORT #: MW5178935. WE BELIVE A MISTAKE HAVE BEEN MADE THE SCREW WOULD BE: BEVELED COMPRESSIVE IMPLANT Ø4 LG60 THAT WOULD BE THE FOLLOWING REF: PS050160. ANOTHER DETAIL THAT WE WOULD LIKE TO CLARIFY WE DO NOT HAVE SUCH LOT NUMBER, THE LOT NUMBER H0177A DOES NOT EXIST FOR OUR PRODUCTS, THE CLOSEST BATCH NUMBER WOULD BE: H01775. THEREFORE, WE ARE UNABLE TO INVESTIGATE THIS ISSUE, AS WE DO NOT HAVE THE CORRECT REFERENCE OR THE APPROPRIATE LOT NUMBER.

  Patient problems: Implant Pain

  MAUDE report 23933111 ↗