ChronOS 07.801.101.99SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034753706), received between Apr 20, 2020 and Apr 20, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CHRONOS BETA TCP STRIP CAUSED A POST-OPERATIVE INFECTION. THE REPORTED DEVICE WAS IMPLANTED ON (B)(6) 2019 AND THE ISSUE WAS DISCOVERED DURING A POST-OP VISIT. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9978007 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CHRONOS BETA TCP STRIP CAUSED A POST-OPERATIVE INFECTION. THE REPORTED DEVICE WAS IMPLANTED ON (B)(6) 2018. THE ISSUE WAS DISCOVERED DURING A POST-OP VISIT. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT INVOLVES ONE (1) CHRONOS (TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES THE REPORTED EVENT INVOLVING PATIENT TWO (2) WITH CHRONOS STRIP LOT DS700911, IMPLANTED ON (B)(6) 2019. THIS REPORT IS FOR (B)(4) AND WILL CAPTURE THE EVENT INVOLVING PATIENT ONE (1) WITH CHRONOS STRIP LOT # DSE8043, IMPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9977972 ↗