Matrix 04.606.650Recalls & reported problems
Synthes GmbH · 6.0MM TI CANN MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034735559), received between Feb 22, 2018 and Feb 13, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2019Break; Break
CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND UNKNOWN MATRIX SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN).
Patient problems: No Code Available; Pain
MAUDE report 8335743 ↗MalfunctionMar 30, 2018Break; Break
THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7385392 ↗MalfunctionFeb 22, 2018Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT OF AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SPINE PROCEDURE ON (B)(6) 2017, WHILE FINAL TIGHTENING A SYNTHES 6.0MM MATRIX TITANIUM (TI) POLYAXIAL SCREW, 50MM, THE HEAD OF THE SCREW SHEARED OFF FROM THE BODY OF THE SCREW. THE HEAD OF THE SCREW WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7290743 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.