Matrix 04.639.860Recalls & reported problems
Synthes GmbH · 8.0MM TI MATRIX SCREW 60MM THREAD LENGTH · Class 2 · Implant
All models of Matrix (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034749624), received between Jan 8, 2024 and Jan 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
Patient problems
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE T-PAL TI AND MATRIX PRODUCT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Osteolysis
MAUDE report 18468308 ↗
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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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