2t11 #2 Pdo 36 X 36 RA-1065QRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782019168), received between Aug 24, 2023 and Aug 24, 2023 — classified as 1 injury.

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

• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT "VERTEBROPLASTY" (A PROCEDURE IN WHICH A SPECIAL CEMENT IS INJECTED INTO A FRACTURED VERTEBRA ¿ WITH THE GOAL OF RELIEVING SPINAL PAIN AND RESTORING MOBILITY. NOT ALL PEOPLE WITH FRACTURED VERTEBRAE ARE CANDIDATES FOR THE PROCEDURE), DURING WHICH SUTURE WAS USED TO CLOSE THE WOUND. POST-OPERATIVELY, THE PATIENT'S WOUND BECAME RED, SWOLLEN AND OOZING. ADDITIONAL DETAILS RECEIVED 08/15/2023: (B)(6) 2023 THE PATIENT PRESENTED WITH A RED, OOZING INCISION THAT REQUIRED AN ADDITIONAL PROCEDURE TO CLEAN THE INCISION. NO ADDITIONAL DETAILS OF THE PROCEDURE PERFORMED, PATIENT HEALTH STATUS PRIOR TO THE PROCEDURE, PREVIOUS REACTIONS TO SUTURE MATERIALS WERE PROVIDED, NO CULTURES RESULTS WERE PROVIDED TO DETERMINE IF INFECTION WAS PRESENT. NO DETAILS WERE DISCLOSED IF ANTIBIOTICS WERE ADMINISTERED OR POST-OPERATIVE INSTRUCTIONS. THE PATIENT RECOVERED WITHOUT FURTHER COMPLICATION.

  Patient problems: Inflammation

  MAUDE report 17620643 ↗