Airlock® XSD02002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879500980), received between Nov 26, 2020 and Nov 26, 2020 — classified as 1 injury.

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

• InjuryNov 26, 2020Break

  DATE OF INCIDENT: (B)(6) 2020. DESCRIPTION: THE TIP OF THE SCREWDRIVER BROKE WHILE SCREWING A LOCKING SCREW 3.5 (SP0135XX) DURING THE IMPLANTATION OF A LISFRANC PLATE. NO EXPLANTATION REQUIRED, BUT THE TIP COULD NOT BE REMOVED FROM THE PATIENT'S BODY, IT WAS MAINTAINED IN THE TORX FOOTPRINT. MORE DETAILS RECEIVED ON THE 12TH OF NOVEMBER 2020 : THE BREAKAGE HAPPENED "AT THE END OF SCREWING IN". THE TIP REMAINED "FLUSH IN THE SCREW". THE SURGERY WAS PERFORMED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10911396 ↗