RibLoc RBL1302Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10814493010388), received between Aug 16, 2016 and May 19, 2020 — classified as 14 injuries.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2020Break

  PATIENT WAS COMPLAINING OF DISCOMFORT/PAIN AND REQUESTED PLATE REMOVAL. DATE OF INITIAL SURGERY WAS (B)(6) 2020. DATE OF REMOVAL SURGERY WAS (B)(6) 2020. SCREWS WERE REMOVED AND THEN THE PLATE WAS REMOVED. DURING THE REMOVAL SURGERY BOTH POSTERIOR CLAMPS BROKE. PLATE WAS NOT BROKEN BEFORE REMOVAL. ONE WAS REMOVED AND ONE WAS LEFT IN SITU. SURGEON DID NOT EXPRESS CONCERN ABOUT LEAVING THE POSTERIOR ASPECT OF PLATE IN PATIENT.

  Patient problems: Discomfort; Pain

  MAUDE report 10072203 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS PLATED APPROXIMATELY ONE YEAR PRIOR. PATIENT COMPLAINED OF LIMITED FUNCTION DUE TO PREVIOUS RIB SURGERY. SURGEONS DETERMINED PLATING CAUSE OF LIMITED FUNCTION. TWO PLATES REMOVED. REPORT 2 OF 2.

  Patient problems: Discomfort

  MAUDE report 7778535 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS PLATED APPROXIMATELY ONE YEAR PRIOR. PATIENT COMPLAINED OF LIMITED FUNCTION DUE TO PREVIOUS RIB SURGERY. SURGEONS DETERMINED PLATING CAUSE OF LIMITED FUNCTION. TWO PLATES REMOVED. REPORT 1 OF 2.

  Patient problems: Discomfort

  MAUDE report 7777526 ↗
• InjuryApr 5, 2018Break; Break

  PATIENT WAS LIFTING HEAVY LOAD THAT RESULTED IN HARDWARE BREAKING. THE SURGEON IS CONFIDENT THAT PATIENT'S ACTIONS WERE NON-COMPLIANT WITH POST SURGERY INSTRUCTIONS. THE PLATE BROKE. THE SCREWS WERE STILL IN THE BONE. THIS IS SUBMISSION 2 OF 2. PRODUCT WAS RETURNED AND IT WAS DISCOVERED THERE WERE TWO AFFECTED PARTS, THIS SUBMISSION IS TO CAPTURE THE SECOND PART.

  Patient problems: Failure of Implant

  MAUDE report 7401613 ↗
• InjuryApr 2, 2018Break; Break

  PATIENT WAS LIFTING HEAVY LOAD THAT RESULTED IN HARDWARE BREAKING. THE SURGEON IS CONFIDENT THAT PATIENT'S ACTIONS WERE NON-COMPLIANT WITH POST SURGERY INSTRUCTIONS. THE PLATE BROKE. THE SCREWS WERE STILL IN THE BONE.

  Patient problems: Failure of Implant

  MAUDE report 7390595 ↗
• InjurySep 18, 2017Break; Break

  PATIENT WAS PLATED (B)(6) 2016 TO TREAT 3 BROKEN RIBS FROM A HORSEBACK RIDING ACCIDENT. ON 08/08/2017 THE SALES REP NOTIFIED ACUTE THAT XRAY FILMS SHOWED THAT 2 OF THE 3 PLATES HAD BROKEN AND REVISION SURGERY WAS PLANNED. IT IS UNKNOWN WHEN THE FIRST PLATE BROKE, THE SECOND PLATE BROKE (B)(6) 2017. IT WAS STATED IN THE MEDICAL HISTORY THAT THE PATIENT FELL AT SOME UNKNOWN TIME AFTER THE INITIAL SURGERY. DETAILS OF THE FALL ARE NOT PROVIDED. PLATES RETURNED WERE INSPECTED, THE ENDS OF THE BREAKS FOR BOTH PLATES WERE RUBBED SMOOTH WHICH INDICATES THAT THE PLATES FRACTURED AND RUBBED TOGETHER FOR AN UNKNOWN SIGNIFICANT AMOUNT OF TIME. BOTH PLATES MET PRINT SPECIFICATIONS. THE BROKEN RIBS WERE REPLATED. ALL SCREWS USED TO SECURE THE PLATE WERE RETURNED - 8 IN ALL- THESE SHOWED NORMAL WEAR FOR INSTALLATION AND REMOVAL OF PLATE. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 6872969 ↗
• InjurySep 18, 2017Break; Break

  PATIENT WAS PLATED (B)(6) 2016 TO TREAT 3 BROKEN RIBS FROM A HORSEBACK RIDING ACCIDENT. ON 08/08/2017 THE SALES REP NOTIFIED ACUTE THAT XRAY FILMS SHOWED THAT 2 OF THE 3 PLATES HAD BROKEN AND REVISION SURGERY WAS PLANNED. IT IS UNKNOWN WHEN THE FIRST PLATE BROKE, THE SECOND PLATE BROKE (B)(6) 2017. IT WAS STATED IN THE MEDICAL HISTORY THAT THE PATIENT FELL AT SOME UNKNOWN TIME AFTER THE INITIAL SURGERY. DETAILS OF THE FALL ARE NOT PROVIDED. PLATES RETURNED WERE INSPECTED, THE ENDS OF THE BREAKS FOR BOTH PLATES WERE RUBBED SMOOTH WHICH INDICATES THAT THE PLATES FRACTURED AND RUBBED TOGETHER FOR AN UNKNOWN SIGNIFICANT AMOUNT OF TIME. BOTH PLATES MET PRINT SPECIFICATIONS. THE BROKEN RIBS WERE REPLATED. ALL SCREWS USED TO SECURE THE PLATE WERE RETURNED - 8 IN ALL- THESE SHOWED NORMAL WEAR FOR INSTALLATION AND REMOVAL OF PLATE. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 6872930 ↗
• InjuryJul 11, 2017Missing Value Reason; Missing Value Reason

  IT WAS REPORTED THAT PLATE REMOVAL SURGERY WAS PERFORMED DUE TO CHRONIC INFECTION. PLATES AND SCREWS WERE REMOVED. INVESTIGATION OF RETURNED IMPLANTS SHOWED WEAR CONSISTENT WITH IMPLANTATION AND REMOVAL; PLATE COMPRESSION TABS WERE BROKEN OFF, ALL BROKEN PIECES WERE RETURNED. THE SURGEON INDICATED THE PRESENCE OF THE PLATES WERE CONTRIBUTING TO THE CHRONIC INFECTION. THIS PRODUCT IS SUPPLIED NON-STERILE AND IS CLEANED AND STERILIZED AT THE USER FACILITY PRIOR TO SURGERY.

  Patient problems: Bacterial Infection

  MAUDE report 6702489 ↗
• InjuryApr 17, 2017Insufficient Device Problem Information

  PLATE REMOVAL DUE TO ADHESIONS UNDER SCAPULA FROM SCAR TISSUE OF INCISION. RIBS WERE HEALED DURING REMOVAL AND REMOVAL WAS DONE WITHOUT ISSUE IN (B)(6) 2016.

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 6497032 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2016, FIVE RIB PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. THE PATIENT DEVELOPED AN INFECTION AND ALL FIVE PLATES WERE REMOVED ON (B)(6) 2016. PLATES WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: Unspecified Infection

  MAUDE report 5881004 ↗
• InjuryAug 16, 2016Insufficient Device Problem Information

  IN (B)(6) 2016, FIVE RIB PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. THE PATIENT DEVELOPED AN INFECTION AND ALL FIVE PLATES WERE REMOVED ON (B)(6) 2016. PLATES WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: Unspecified Infection

  MAUDE report 5881003 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2016, FIVE RIB PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. THE PATIENT DEVELOPED AN INFECTION AND ALL FIVE PLATES WERE REMOVED ON (B)(6) 2016. PLATES WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: Unspecified Infection

  MAUDE report 5881001 ↗
• InjuryAug 16, 2016Insufficient Device Problem Information

  ON APPROXIMATELY (B)(6) 2014, SEVEN RIBLOC U PLUS PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. ON (B)(6) 2015, 4 PLATES WERE REMOVED DUE TO PATIENT COMPLAINTS OF DISCOMFORT; 3 PLATES WERE LEFT IN PLACE. NONE OF THE PLATES REMOVED WERE RETURNED FOR INVESTIGATION, HOWEVER. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE IMPLANTS (PLATES AND SCREWS) AND THERE WAS NO MENTION BY THE USER OF AN APPARENT INSTALLATION ERROR AND YET THE BONES HAD NOT HEALED AFTER BEING INSTALLED FOR 16 MONTHS.

  Patient problems: Discomfort; Impaired Healing

  MAUDE report 5880982 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  ON APPROXIMATELY (B)(6) 2014, SEVEN RIBLOC U PLUS PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. ON (B)(6) 2015, 4 PLATES WERE REMOVED DUE TO PATIENT COMPLAINTS OF DISCOMFORT; 3 PLATES WERE LEFT IN PLACE. NONE OF THE PLATES REMOVED WERE RETURNED FOR INVESTIGATION, HOWEVER. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE IMPLANTS (PLATES AND SCREWS) AND THERE WAS NO MENTION BY THE USER OF AN APPARENT INSTALLATION ERROR AND YET THE BONES HAD NOT HEALED AFTER BEING INSTALLED FOR 16 MONTHS.

  Patient problems: Discomfort

  MAUDE report 5880977 ↗