RibLoc RBL1304Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10814493010401), received between Aug 16, 2016 and Aug 13, 2018 — classified as 8 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2018Break; Break

  PATIENT HAD RIB PLATE INSTALLED ABOUT A YEAR AGO (2017) AS PART OF A CHEST WALL RECONSTRUCTION. THE PLATE BROKE AND REVISION SURGERY WAS PERFORMED TO REMOVE THE PLATE. ADDITIONALLY THERE WAS SOME WIRE USED TO WRAP AROUND THE PLATE AND BONE, THIS WIRE IS NOT PART OR ACUTE PRODUCT LINE. THE RIB PLATE AND FOUR SCREWS WERE REMOVED. THE BROKEN EDGES OF THE PLATE WERE BENT, DEFORMED AND WORN SMOOTH, INDICATING THAT THE EDGES LIKELY RUBBED AGAINST EACH OTHER. THE SCREW HEADS SHOWED SOME WEAR LIKELY FROM THE WIRE RUBBING ON THE SCREW HEADS, OTHERWISE SCREWS WERE UNDAMAGED.

  Patient problems: Failure of Implant

  MAUDE report 7778555 ↗
• InjuryMay 9, 2017Break; Insufficient Device Problem Information; Missing Value Reason; Break; Insufficient Device Problem Information; Missing Value Reason

  PLATE REMOVAL CAUSE UNKNOWN. SURGEON REMOVED PLATE FROM LOWER RIB (9 OR 10) BUT HAD TO LEAVE PART OF THE PLATE IN PLACE BECAUSE HE COULD NOT REMOVE IT COMPLETELY. SURGEON BROKE THE PLATE IN A FEW PIECES AND WAS ABLE TO REMOVE MOST OF IT. POSTERIOR PART OF THE PLATE REMAINED INTACT. IT WAS REPORTED THAT THE FRACTURE HAD HEALED AND REPLATING WAS NOT NECESSARY. PLATES BEING RETURNED FOR INVESTIGATION. EVENT UPDATE: THE SURGEON REPORTED THE FOLLOWING: THE PATIENT IS A (B)(6)GENTLEMAN 6 FOOT (B)(6) IN GOOD SHAPE FAIRLY MUSCULAR HE WAS INVOLVED IN A MOTORCYCLE ACCIDENT AROUND TWO YEARS AGO AND SUSTAINED MULTIPLE RIGHT SIDED RIB FRACTURES THAT WERE TREATED CONSERVATIVELY HE PRESENTED TO ME SEVERAL MONTHS AFTER THE ACCIDENT (ALMOST A YEAR ) WITH PAIN FORM A DISPLACED NONUNION FOR THE 8TH OF RIB POSTERIOR LATERALLY. I TOOK HIM TO THE OPERATING ROOM (OR) WHERE I WAS ABLE TO REDUCE THE FRACTURE AND RE APPROXIMATE THE RIB AND PLACED THE RIB LOCK PLATE (I BELIEVE TOM HAS SUPPLIED YOU WITH DETAIL OF SIZE AND SCREWS. HE HAD AN EXCELLENT POST OP RESULT WITH RESOLUTION OF PAIN AND WAS ABLE TO RETURN BACK TO NORMAL DAILY ACTIVITIES. HE PRESENTED BACK TO US ABOUT 2 MONTHS AGO WITH A RATHER SUDDEN ONS

  Patient problems: Discomfort; Missing Value Reason; No Information; Patient Problem/Medical Problem

  MAUDE report 6553518 ↗
• InjuryApr 17, 2017Loose or Intermittent Connection

  WOUND INFECTION LED TO REMOVAL OF PLATE AT SITE OF INFECTION. THE INTERMEDIATE SCREWS HAD LOOSENED UP DUE TO BONE ATROPHY FROM THE INFECTION. THE SALES REPRESENTATIVE REPORTED THAT THE INFECTION IS BELIEVED TO HAVE BEEN CAUSED BY THE SURGICAL SITE. PATIENT OUTCOME WAS SUCCESSFUL. PLATES AND SCREWS WERE NOT RETRIEVED AFTER REMOVAL AND WILL NOT BE RETURNED; NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6497064 ↗
• InjuryApr 17, 2017Loose or Intermittent Connection

  WOUND INFECTION LED TO REMOVAL OF PLATE AT SITE OF INFECTION. THE INTERMEDIATE SCREWS HAD LOOSENED UP DUE TO BONE ATROPHY FROM THE INFECTION. THE SALES REPRESENTATIVE REPORTED THAT THE INFECTION IS BELIEVED TO HAVE BEEN CAUSED BY THE SURGICAL SITE. PATIENT OUTCOME WAS SUCCESSFUL. PLATES AND SCREWS WERE NOT RETRIEVED AFTER REMOVAL AND WILL NOT BE RETURNED; NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REPORT 1 OF 5.

  Patient problems: Unspecified Infection

  MAUDE report 6497052 ↗
• InjuryApr 17, 2017Loose or Intermittent Connection

  WOUND INFECTION LED TO REMOVAL OF PLATE AT SITE OF INFECTION. THE INTERMEDIATE SCREWS HAD LOOSENED UP DUE TO BONE ATROPHY FROM THE INFECTION. THE SALES REPRESENTATIVE REPORTED THAT THE INFECTION IS BELIEVED TO HAVE BEEN CAUSED BY THE SURGICAL SITE. PATIENT OUTCOME WAS SUCCESSFUL. PLATES AND SCREWS WERE NOT RETRIEVED AFTER REMOVAL AND WILL NOT BE RETURNED; NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REPORT 4 OF 5.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6497044 ↗
• InjuryApr 17, 2017Device Slipped

  WOUND INFECTION LED TO REMOVAL OF PLATE AT SITE OF INFECTION. THE INTERMEDIATE SCREWS HAD LOOSENED UP DUE TO BONE ATROPHY FROM THE INFECTION. THE SALES REPRESENTATIVE REPORTED THAT THE INFECTION IS BELIEVED TO HAVE BEEN CAUSED BY THE SURGICAL SITE. PATIENT OUTCOME WAS SUCCESSFUL. PLATES AND SCREWS WERE NOT RETRIEVED AFTER REMOVAL AND WILL NOT BE RETURNED; NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REPORT 3 OF 5

  Patient problems: Osteolysis; Post Operative Wound Infection

  MAUDE report 6497043 ↗
• InjuryApr 17, 2017Loose or Intermittent Connection

  WOUND INFECTION LED TO REMOVAL OF PLATE AT SITE OF INFECTION. THE INTERMEDIATE SCREWS HAD LOOSENED UP DUE TO BONE ATROPHY FROM THE INFECTION. THE SALES REPRESENTATIVE REPORTED THAT THE INFECTION IS BELIEVED TO HAVE BEEN CAUSED BY THE SURGICAL SITE. PATIENT OUTCOME WAS SUCCESSFUL. PLATES AND SCREWS WERE NOT RETRIEVED AFTER REMOVAL AND WILL NOT BE RETURNED; NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6497038 ↗
• 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; Impaired Healing

  MAUDE report 5880987 ↗