Matrix 04.632.750Recalls & reported problems
Synthes GmbH · 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034745688), received between Jan 24, 2017 and May 24, 2019 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device-Device Incompatibility1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2019Break; Break
CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8640083 ↗MalfunctionOct 12, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR REVISION FUSION PROCEDURE ON (B)(6) 2018, A MATRIX POLYAXIAL SCREW WOULD NOT LOCK DOWN PROPERLY. SURGEON REMOVED THE SCREW AND NOTED IT WAS DEFECTIVE. ANOTHER SCREW WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 7.0MM MATRIX POLYAXIAL SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7963339 ↗MalfunctionFeb 14, 2017Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN INITIAL DEGENERATIVE LUMBAR POSTERIOR FUSION ON (B)(6) 2016, THE HEAD OF A 7.0 MM TITANIUM MATRIX POLYAXIAL SCREW 50 MM THREAD LENGTH CAME OFF OF THE SHAFT OF THE SCREW AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING A SAME/LIKE PRODUCT. SURGICAL DELAY AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6329724 ↗InjuryJan 24, 2017Break; Break
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: (B)(6) REPORT NUMBER: (B)(4) REPORTED THAT A POLY SCREW 7 MM X 50 MM HEAD BROKE. SURGEON WAS ABLE TO REMOVE THE OTHER PART SCREW AND REPLACE WITH A NEW SCREW. THE SCREW IS FROM MATRIX DEGEN SET. THERE IS 1 DEVICE IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 6273075 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.