NA 04.501.116.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587017426), received between Oct 3, 2018 and Apr 15, 2019 — classified as 5 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 8514204 ↗
• 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 8514177 ↗
• 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 8514146 ↗
• 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 8514105 ↗
• 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: (B)(6) 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 8514079 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT STERNOTOMY. WHILE TIGHTENING A SELF-DRILLING SCREW INTO A STERNAL LOCKING H PLATE, THE HOLE OF THE PLATE WITH THE SCREW STILL INTACT GOT SEPARATED FROM THE REST OF THE PLATE. THE HOLE WITH THE SCREW STILL SITTING IN IT WAS REMOVED OFF THE FIELD AND SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT. THE REST OF THIS PLATE REMAINED FIXATED INTO THE STERNUM. THERE WAS NO REPORTED DELAY IN THE PROCEDURE. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932407 ↗