NA 460.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587055152), received between Apr 15, 2019 and Apr 25, 2019 — 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.

• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE(5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING X PLATE 10 HOLES. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8553123 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  UPDATE: APRIL 10, 2019 . THE MALE PATIENT WAS REVISED DUE TO INFECTION. ALL HARDWARE WAS REMOVED INTACT. THE INTERVENTION AFTER THE REMOVAL OF THE IMPLANTS IS UNKNOWN. ALONG WITH THE REPORTED PLATES, THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES: 04.501.112.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM. 04.501.114.01 QTY. (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM. 04.501.116.01 QTY. (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM. 04.501.118.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM.

  Patient problems: Unspecified Infection

  MAUDE report 8513958 ↗