BioBridge RRP1501Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10814493010609), received between Aug 30, 2016 and Jul 10, 2020 — classified as 5 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Break

  PATIENT CAME IN WHO SUFFERED 5 RIB FRACTURES (NUMBERS 4,5,6,7,8). FOUR BIOBRIDGE PLATES WERE USED TO FIXATE TWO OF THE FIVE RIBS (NUMBERS 7 AND 8) AS THERE WERE SIGNIFICANT GAPS IN HIS CHEST WALL FROM THE FRACTURES. THE REMAINING 3 RIBS WERE FIXED WITH RIBLOC UPLUS PLATES AND SCREWS. A WEEK LATER THE PATIENT WAS BOOKED AGAIN FOR SURGERY AS BOTH DOUBLETS OF BIOBRIDGE HAD SNAPPED.

  Patient problems: No Code Available

  MAUDE report 10260875 ↗
• InjuryMar 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PER THE SURGEON WHO PERFORMED THE INITIAL SURGERY IT IS UNDERSTOOD THAT THE PATIENT HAD DEVELOPED SEROMA, WHICH IS NOT UNCOMMON TO DEVELOP POST SURGERY. THE PATIENT CONTACTED ACUTE WITH QUESTIONS REGARDING "INFECTION" AND THE PLATE'S NATURE TO WITHHOLD. THE PATIENT CONSULTED A PLASTIC SURGEON RATHER THAN THE SURGEON WHO PERFORMED THE INITIAL SURGERY. THE PATIENT HAD THE "INFECTION"/SEROMA DRAINED BY THE PLASTIC SURGEON AND THE PLATES (WHICH WERE IMPLANTED IN SMALL PIECES IN THE FIRST PLACE) ALSO GOT DRAINED.

  Patient problems: Missing Value Reason

  MAUDE report 8391303 ↗
• InjuryAug 30, 2016Appropriate Device Problem Term/Code Not Available

  EXPLANT OF BIOBRIDGE PLATES USED IN THE PECTUS REPAIR OF A PEDIATRIC PATIENT. THREE PLATES WERE IMPLANTED (B)(6) 2016. SURGEON KNEW IT WAS OFF-LABEL USE. THE PATIENT DEVELOPED PAINFUL DISCOMFORT DURING MOVEMENT WHICH LED TO REMOVAL OF THE THREE PLATES.

  Patient problems: Discomfort; Pain

  MAUDE report 5916076 ↗
• InjuryAug 30, 2016Nonstandard Device

  EXPLANT OF BIOBRIDGE PLATES USED IN THE PECTUS REPAIR OF A PEDIATRIC PATIENT. THREE PLATES WERE IMPLANTED (B)(6) 2016. SURGEON KNEW IT WAS OFF-LABEL USE. THE PATIENT DEVELOPED PAINFUL DISCOMFORT DURING MOVEMENT WHICH LED TO REMOVAL OF THE THREE PLATES.

  Patient problems: Discomfort; Pain

  MAUDE report 5916071 ↗
• InjuryAug 30, 2016Improper or Incorrect Procedure or Method

  EXPLANT OF BIOBRIDGE PLATES USED IN THE PECTUS REPAIR OF A PEDIATRIC PATIENT. PLATES WERE IMPLANTED (B)(6) 2016. SURGEON KNEW IT WAS OFF-LABEL USE. THE PATIENT DEVELOPED PAINFUL DISCOMFORT DURING MOVEMENT WHICH LED TO REMOVAL OF THE THREE PLATES.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 5916066 ↗