N/A 01-3801Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841036011093), received between May 8, 2019 and Mar 23, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Skin Discoloration

  MAUDE report 24661328 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Skin Discoloration

  MAUDE report 24661316 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Burning Sensation; Erythema; Pain

  MAUDE report 10999115 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body Reaction; Purulent Discharge; Unspecified Infection

  MAUDE report 10645136 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema

  MAUDE report 10499551 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema; Swelling

  MAUDE report 10499548 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema

  MAUDE report 10499545 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS TREATED FOR AN EDEMA AT THE INCISION SITE AND POOR WOUNDING HEALING SEVEN (7) WEEKS FOLLOWING IMPLANTATION OF A PECTUS SUPPORT BAR. AFTER TWO (2) MONTHS OF SYMPTOMATIC TREATMENT, THE INCISION HEALED AND THE EDEMA DISAPPEARED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Edema

  MAUDE report 10484890 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Pain; Swelling

  MAUDE report 10462587 ↗
• InjuryMar 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PECTUS BAR AND STABILIZER WAS REMOVED IN A REVISION APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY AFTER THE BAR SLIPPED OUT OF THE STABILIZER. THE DEVICES WERE REMOVED AND WERE NOT REPLACED. TWELVE TO EIGHTEEN MONTHS FOLLOWING THE REVISION, A RAVITCH PROCEDURE IS PLANNED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9813288 ↗
• InjuryMay 15, 2019Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION DUE TO BAR ROTATION. DURING THE SURGEONS ROUNDS ON POST-OP DAY THREE (3), THE PATIENT REPORTED PAIN. PATIENT EXAMINATION AND IMAGING CONFIRMED BAR ROTATION. A RE-OPERATION WAS PERFORMED ON POST-OP DAY THREE (3) TO CORRECT THE ROTATION AND ADD A STABILIZER. NO PRODUCT WAS REMOVED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8612718 ↗
• InjuryMay 8, 2019Migration; Migration

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8593448 ↗