NA 296.766Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982182487), received between Oct 1, 2021 and Oct 1, 2021 — 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON AN UNKNOWN DATE FOR FIXATION OF A UNILATERAL SACRAL FRACTURE, UTILIZING A SACRAL BAR IMPLANT 260 MM WITH NUTS AND WASHERS (STAINLESS STEEL). POSTOPERATIVELY, THE PATIENT PRESENTED HEMATOMA AND BLEEDING ANEMIA, REOPERATION WAS DUE TO HEMATOMA. HEALING WAS NOT ASSESSABLE BECAUSE OF EARLY MORTALITY. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 6.0MM THREADED SACRAL BAR 260MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hematoma

  MAUDE report 12563292 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON AN UNKNOWN DATE FOR FIXATION OF A UNILATERAL SACRAL FRACTURE, UTILIZING A DPS SACRAL BAR IMPLANT 260 MM WITH NUTS AND WASHERS (STAINLESS STEEL). POSTOPERATIVELY, THE PATIENT PRESENTED AN INFECTION WITH ADVERSE EVENTS OF PNEUMONIA, INTESTINAL PARALYSIS, HYPALBUMINEMIA AND EDEMA. REOPERATION WAS DUE TO INFECTION. THERE WAS A KNOWN HEALING OF FRACTURE. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 6.0MM THREADED SACRAL BAR 260MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12562469 ↗