MatrixRIB 04.501.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587017006), received between Dec 6, 2017 and Dec 19, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PLATES IN QUESTION WERE REMOVED FROM A PATIENT IN WHICH THE FRACTURES WERE COMPLETELY HEALED. THE PLATES WERE ORIGINALLY IMPLANTED APPROXIMATELY 15 YEARS AGO. THE PLATES AND SCREWS WERE NOT BROKEN, THE PATIENT WANTED THE IMPLANTS REMOVED BECAUSE THEY FELT LIKE THEY COULDN¿T TAKE DEEP BREATHS. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Dyspnea

  MAUDE report 18357633 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PLATES IN QUESTION WERE REMOVED FROM A PATIENT IN WHICH THE FRACTURES WERE COMPLETELY HEALED. THE PLATES WERE ORIGINALLY IMPLANTED APPROXIMATELY 15 YEARS AGO. THE PLATES AND SCREWS WERE NOT BROKEN, THE PATIENT WANTED THE IMPLANTS REMOVED BECAUSE THEY FELT LIKE THEY COULDN¿T TAKE DEEP BREATHS. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Dyspnea

  MAUDE report 18356743 ↗
• InjuryJul 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) MATRIX RIB 17 HOLE PLATE AND ONE (1) MATRIX RIB 18 HOLE PLATE WERE EXPLANTED FROM THE PATIENT DUE TO BREAKAGE AND NONUNION. THE DATE OF THE INITIAL IMPLANT SURGERY IS UNKNOWN. THERE WERE NO FRAGMENTS FOUND IN THE PATIENT. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TI MATRIXRIB IM SPLINT MEDIUM-4MM WIDTH (PART# 04.501.011; LOT# UNKNOWN; QUANTITY: 1); 2.9 TI MATRIXRIB LCKNG SCREW STPING/12 (PART# 04.501.022.01, LOT# UNKNOWN; QUANTITY: 1); 2.9 TI MATRIXRIB LCKNG SCREW STPING/14 (PART# 04.501.024.01, LOT# UNKNOWN; QUANTITY: 1); UNK - SCREWS: MATRIXRIB (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 11). THIS REPORT IS FOR ONE (1) TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12228130 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF FIVE (5) TITANIUM MATRIXRIB LOCKING SCREW, ONE (1) TITANIUM MATRIXRIB PRE-CONTOURED PLATE AND THREE (3) TITANIUM MATRIXRIB UNIVERSAL PLATE DUE TO INFECTION THAT HAVE STEMMED FROM THE SOFT TISSUE WOUND BREAKDOWN NEAR THE SITE OF THE IMPLANTS ON THE LEFT RIB. ORIGINALLY, THE IMPLANTS WERE IMPLANTED ON (B)(6) 2019. THE RIB FRACTURES WAS HEALED, HARDWARE WAS REMOVED, AND THE SURGICAL SITE WAS IRRIGATED/DEBRIDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND PATIENT STATUS WAS SATISFACTORY. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS THE REPORT OF (1) TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7. THIS IS REPORT 02 OF 09 OF (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9660590 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PLATES AND SCREWS ON (B)(6) 2018 DUE TO PAIN. THE PATIENT REQUESTED REMOVAL OF THE THREE PLATES, SCREWS, AND FIVE INTERMEDULLARY SPLINTS AS THE PATIENT WAS EXPERIENCING PAIN IN THE AREA OF THE IMPLANTS AND THE PATIENT BELIEVED THE IMPLANTS WERE THE CAUSE. THE SURGEON WAS ABLE TO REMOVE THE THREE PLATES THAT HAD BEEN AFFIXED WITH 22 SCREWS; HOWEVER, THE FIVE INTERMEDULLARY SPLINTS AND THE FIVE SCREWS ASSOCIATED WITH THE SPLINTS WERE NOT ABLE TO BE REMOVED. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7429978 ↗
• InjuryDec 6, 2017Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN RIB PLATE. THE ORIGINAL PROCEDURE, A FRACTURE AT RIB 6, WAS PERFORMED ON AN UNKNOWN DATE. SUBSEQUENTLY IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THERE IS NO INFORMATION REGARDING TRAUMA OR OTHER REASON FOR THE PLATE BREAKAGE. IT WAS NOTED THAT THE PATIENT IS MORBIDLY OBESE. REMOVED HARDWARE INCLUDED: ONE PLATE (BROKEN, EASILY REMOVED) AND EIGHT 2.9MM TITANIUM LOCKING SCREWS -ALL INTACT. THE PATIENT WAS REVISED TO A NEW PLATE AND SCREWS. NOTHING UNTOWARD OCCURRED DURING THE PROCEDURE. NO SURGICAL DELAYS, NO FRAGMENTS INVOLVED, NO ADDITIONAL X-RAYS OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 2.9MM TITANIUM LOCKING SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 8). THIS REPORT IS FOR ONE (1) TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7088203 ↗