PDS ZB347Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031062054), received between Dec 9, 2022 and Jan 10, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (6 reports).

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

• InjuryJan 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE FASCIA. THE PATIENT DEVELOPED A DEEP WOUND INFECTION 2-3 WEEKS POST OP. THE PATIENT REQUIRED EXPLANTATION OF THE IMPLANTS AND WAS SEEN AGAIN ON (B)(6) 2023, 3 WEEKS AFTER THE RE-OPERATION AND THE WOULD HAS COMPLETELY HEALED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16134349 ↗
• InjuryDec 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN EARLY, DEEP SEROMA WITH SUTURE LINE DISRUPTION AND RETURN TO THE OR. HE DID NOT FEEL LIKE THE WOUND WAS INFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15951230 ↗
• InjuryDec 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN EARLY, DEEP SEROMA WITH SUTURE LINE DISRUPTION AND RETURN TO THE OR. HE DID NOT FEEL LIKE THE WOUND WAS INFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15951226 ↗
• InjuryDec 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN EARLY, DEEP SEROMA WITH SUTURE LINE DISRUPTION AND RETURN TO THE OR. HE DID NOT FEEL LIKE THE WOUND WAS INFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15951224 ↗
• InjuryDec 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN EARLY, DEEP SEROMA WITH SUTURE LINE DISRUPTION AND RETURN TO THE OR. HE DID NOT FEEL LIKE THE WOUND WAS INFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15951203 ↗
• InjuryDec 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN EARLY, DEEP SEROMA WITH SUTURE LINE DISRUPTION AND RETURN TO THE OR. HE DID NOT FEEL LIKE THE WOUND WAS INFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15951201 ↗