MatrixRIB 04.501.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587017044), received between Apr 4, 2018 and Dec 19, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 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 18 HOLES FOR LEFT RIBS 8 & 9. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Dyspnea

  MAUDE report 18357646 ↗
• 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 18 HOLES FOR LEFT RIBS 8 & 9. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12228210 ↗
• InjuryApr 12, 2019Break; Break

  IT WAS FURTHER REPORTED THAT THE INITIAL DATE OF SURGERY TO FIX 2 TITANIUM PLATES WAS (B)(6)2018. AFTER MEDICAL SURGERY (FIXATION OF 2 TITANIUM BARS OF THE LEFT SUPERIOR COSTAL ARCHES), ONE (1) PLATE BROKE INSIDE OF THE PATIENT (COSTAL ARCHES), FORCING HER TO UNDERGO A SECOND (2ND) SURGERY TO REMOVE THAT BROKEN PLATE AND REPLACE WITH ANOTHER ONE, WHICH TURNED OUT TO BE UNNECESSARY. BUT AS A RESULT OF IT, PATIENT IS HAVING SEVERE PAINS. PATIENT CAN'T TURN TO LEFT SIDE. PATIENT CAN'T WORK BECAUSE OF THE SEVERE PAIN AND CAN'T EVEN SLEEP COMPLETELY LYING ON THE BED. PATIENT HAS "ETERNAL PAIN¿, WHICH DOES NOT MITIGATES WITH MEDICINES, PREVENTING HER FROM WORKING AND HAVING A NORMAL LIFE, AS SHE HAD PRIOR TO THOSE SURGERIES.

  Patient problems: No Code Available; Pain

  MAUDE report 8509223 ↗
• InjuryApr 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON FRIDAY (B)(6) 2018 DUE TO LOOSING SCREWS. DURING THE REMOVAL SURGERY, AS THE SURGEON ATTEMPTED TO REMOVE THE PLATE FROM THE RIB, IT WAS DISCOVERED THAT ONE OF THE SCREWS HAD STRIPPED INTO THE PLATE, BINDING THEM TOGETHER. THIS DISCOVERY CAUSED A 5 MINUTE DELAY IN SURGERY, AS THE SURGEON ATTEMPTED TO SEPARATE THE SCREW FROM THE PLATE. UNFORTUNATELY, THE SURGEON WAS UNABLE TO SEPARATE THE TWO DEVICES AND HAD TO CUT OUT THE PATIENT¿S RIB IN ORDER TO REMOVE THE HARDWARE. ALL THE SCREWS AND THE PLATE WERE REMOVED DURING THE (B)(6) 2018 PROCEDURE. THIS REPORT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7398106 ↗