Matrix 04.632.860Recalls & reported problems
Synthes GmbH · 8.0MM TI MATRIX POLYAXIAL SCREW 60MM 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034745848), received between Aug 22, 2018 and Aug 22, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT A TITANIUM MATRIX POLYAXIAL SCREW WAS DAMAGED AND WAS NOT ALLOWING THE ROD AND SET SCREW TO PROPERLY LOCK DOWN DURING REVISION OF POSTERIOR SPINAL SURGERY ON (B)(6) 2018. THE PATIENT HAD SYNTHES MATRIX HARDWARE PREVIOUSLY IMPLANTED AND WAS SCHEDULED FOR REVISION DUE TO ADJACENT LEVEL DISEASE. THE SURGEON REMOVED THE LOCKING CAPS AND PROCEEDED TO IMPLANT S2 AND PELVIC SCREWS. AFTER A NEW ROD AND SET SCREWS WERE PLACED AND LOCKED DOWN, THE SURGEON NOTICED THAT THE SET SCREW ON THE PATIENT¿S LEFT SIDE WAS SITTING PROUD. THE SURGEON PROCEEDED TO TAKE THE LOCKING CAP AND ROD OFF. HE NOTICED THAT THE COLLAR CONNECTING SCREW SHAFT AND TULIP OF TITANIUM MATRIX POLYAXIAL SCREW HAD SHIFTED AND WAS NOT ALLOWING THE ROD AND SET SCREW TO BE PROPERLY LOCKED DOWN. HE PROCEEDED TO REMOVE THE DAMAGED MATRIX SCREW AND REPLACED IT WITH THE NEW ONE. THE DAMAGED MATRIX SCREW WAS EASILY REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THERE WAS A THIRTY-MINUTE SURGICAL DELAY TO REMOVE THE ROD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER MEDICAL INTERVENTION REQUIRED AND NO PATIENT CONSEQUENCE. THE PATIENT OUTCOME WAS REPORTED AS FINE. REVISION SURGERY DUE TO ADJACENT LEVEL DISEAS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7804471 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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