MatrixMANDIBLE SD449.503BRecalls & reported problems
Synthes GmbH · TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK · Class 2 · Implant
All models of MatrixMANDIBLE (79)
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 10887587004556), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
Patient problems
- Injury1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2019Defective Device; Defective Device
CONCOMITANT DEVICE REPORTED: PATIENT SPECIFIC INSTRUMENT/IMPLANT KIT (PART # SD.900.001 , LOT # UNKNOWN, QUANTITY # 1), TITANIUM (TI) MATRIXMANDIBLE SCREW SELF-TAPPING 6MM (PART # 04.503.406.01, LOT # UNKNOWN, QUANTITY # 2), TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM (PART # 04.503.408.01, LOT # UNKNOWN, QUANTITY # 2), TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM (PART # 04.503.408.01, LOT # UNKNOWN, QUANTITY # 9), TI MATRIXMANDIBLE SCREW SELF-TAPPING 14MM (PART # 04.503.414.01, LOT # UNKNOWN, QUANTITY # 1), TI MATRIXMANDIBLE LOCKING SCREW SELF-TAPPING 8MM (PART # 04.503.608.01, LOT # UNKNOWN, QUANTITY # 5), UNKNOWN SCREWS (PART # 04.503.601.01,, LOT # UNKNOWN, QUANTITY # 5), TI MATRIXMANDIBLE LOCKING SCREW SELF-TAPPING 12MM (PART # 04.503.612.01, LOT # UNKNOWN, QUANTITY # 2).
Patient problems: Injury; No Code Available
MAUDE report 9330269 ↗
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- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 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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