MatrixRIB 04.501.018.01Recalls & reported problems
Synthes GmbH · 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/8MM · Class 2 · Implant
All models of MatrixRIB (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587017150), received between Oct 10, 2022 and May 8, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Break1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT THIS EVENT INVOLVED 1 SCREW AND 1 PLATE. IT WAS REPORTED THAT DURING THE SURGERY, METAL DEBRIS APPEARS DURING TIGHTENING THE SCREW TO THE LAST TURN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122228 ↗InjuryAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA PHONE TODAY STATES THAT AFTER INVESTIGATION, THE PATIENT UNDERWENT RIB FRACTURE INTERNAL FIXATION ON (B)(6) 2024 DUE TO "RIB FRACTURE", AND 04.501.018.01 AND 04.501.096 WERE IMPLANTED DURING THE SURGERY. THE SURGICAL PROCESS AND POSTOPERATIVE REHABILITATION OF THE PATIENT WERE UNKNOWN. ON (B)(6) 2025, THE PATIENT UNDERWENT RIB FRACTURE INTERNAL FIXATION REMOVAL. DURING REMOVING THE SCREWS AND PLATES WITH MATCHING TOOLS, THE TWO SCREWS WERE RESPECTIVELY EMBEDDED ON THE TWO PLATES AND COULD NOT BE SCREWED OUT. FINALLY, THE SURGEON HAVE TO PULL OUT THE PLATE AND SCREWS AT THE SAME TIME. THE SURGICAL TIME WAS EXTENDED DURING THIS PERIOD BY APPROXIMATELY 1.5 HOURS. THIS EVENT DID NOT CAUSE ANY OTHER HARM TO THE PATIENT EXCEPT FOR THE PROLONGED OPERATION TIME. THE PATIENT HAS BEEN DISCHARGED SMOOTHLY CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771548 ↗InjuryAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA PHONE TODAY STATES THAT AFTER INVESTIGATION, THE PATIENT UNDERWENT RIB FRACTURE INTERNAL FIXATION ON (B)(6) 2024 DUE TO "RIB FRACTURE", AND 04.501.018.01 AND 04.501.096 WERE IMPLANTED DURING THE SURGERY. THE SURGICAL PROCESS AND POSTOPERATIVE REHABILITATION OF THE PATIENT WERE UNKNOWN. ON (B)(6) 2025, THE PATIENT UNDERWENT RIB FRACTURE INTERNAL FIXATION REMOVAL. DURING REMOVING THE SCREWS AND PLATES WITH MATCHING TOOLS, THE TWO SCREWS WERE RESPECTIVELY EMBEDDED ON THE TWO PLATES AND COULD NOT BE SCREWED OUT. FINALLY, THE SURGEON HAVE TO PULL OUT THE PLATE AND SCREWS AT THE SAME TIME. THE SURGICAL TIME WAS EXTENDED DURING THIS PERIOD BY APPROXIMATELY 1.5 HOURS. THIS EVENT DID NOT CAUSE ANY OTHER HARM TO THE PATIENT EXCEPT FOR THE PROLONGED OPERATION TIME. THE PATIENT HAS BEEN DISCHARGED SMOOTHLY CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771423 ↗MalfunctionNov 7, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON OCTOBER 19, 2023. DURING SURGERY, THE PLATE AND SCREW GOT STUCK, AND THEY BECAME UNABLE TO BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)LOCK SCREW ø2.9 SELF-TAP L8 TAN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18083245 ↗MalfunctionOct 10, 2022Device Slipped; Device Slipped
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SCREW WAS FOUND TO BE LOOSE DURING A POST-OP EXAMINATION. THE INITIAL SURGERY FOR TREATING THE RIB WAS PERFORMED ON (B)(6) 2022. THE PATIENT HAS NO PAIN OR IRRITATION/UNCOMFORTABLE FEELING. AT PRESENT, IT IS UNLIKELY THAT THE SCREW WOULD FALL INTO THE THORACIC CAVITY, AND THE PATIENT DID NOT DEVELOP ANY SUBJECTIVE SYMPTOMS, SO IT WAS DECIDED THAT THE PATIENT WOULD BE FOLLOWED UP AT THE DISCRETION OF THE SURGEON THIS REPORT INVOLVES ONE (1) 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15569851 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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