Matrix 04.632.745Recalls & reported problems
Synthes GmbH · 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH · Class 2 · Implant
Data updated Oct 13, 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 10705034745671), received between Sep 24, 2020 and Sep 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Compatibility Problem1
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.
MalfunctionSep 24, 2020Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX BROKE OFF WHILE THE SURGEON WAS PERFORMING A L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND USING MATRIX HEADLESS SYSTEM. WHEN THE SURGEON WENT TO ATTACH THE TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD TO THE TITANIUM MATRIX POLYAXIAL SCREW HE HAD DIFFICULTY SEATING THE HEAD. THE SURGEON THEN ASKED FOR AN UNKNOWN MALLET TO IMPACT IT ON. THE SURGEON RETRIEVED THE BROKEN FRAGMENT AND SWITCHED TO A DIFFERENT INSERTER AND WAS ABLE TO POP ON THE HEAD WITHOUT ISSUE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX (PART NUMBER 03.632.037, LOT 6624739, QUANTITY 1), TI MATRIX TOP LOADING POLYAXIAL HEAD (PART 04.632.001, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10580185 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page