Matrix 04.632.955Recalls & reported problems
Synthes GmbH · 9.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH · Class 2 · Implant
All models of Matrix (80)
Data updated Oct 16, 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 10705034745961), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
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.
InjuryAug 9, 2023Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WHERE L4 TO S1 WERE FIXED WITH MATRIX IMPLANTS. AFTER SURGERY, ASD OCCURRED AND A REVISION SURGERY WAS SCHEDULED. AT THE TIME OF THE REVISION PROCEDURE, THE MATRIX SCREW IN QUESTION WAS FOUND TO BE LOOSE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 17487396 ↗
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- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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