MatrixMANDIBLE 04.503.752Recalls & reported problems
Synthes GmbH · MATRIXMANDIBLE MINI PL-TENSION BAND BRD/3X3H/MALLEABLE/1.0MM · Class 2 · Implant
- 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 10887587022949), received between Aug 24, 2022 and Aug 24, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2022Migration; Migration
DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT RECEIVED RIGHT LINGUAL MAXILLO-CERVICAL RADICAL OPERATION PLUS LEFT ANTEROLATERAL THIGH SKIN TRANSFER REPAIR AND WAS DISCHARGED ON (B)(6) 2022. INTRAORAL HEMORRHAGE AND MANDIBULAR MOBILITY OCCURRED AFTER DISCHARGE, AND THE PATIENT WENT TO THE HOSPITAL FOR EXAMINATION ON (B)(6) 2022. ACCORDING TO THE PANORAMIC RADIOGRAPH, THE PLATE WAS FRACTURED AND THE MANDIBLE WAS MISPOSITIONED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE ORIGINAL IMPLANTED DEVICE AND REIMPLANT PLATES AND SCREWS OF THE SAME MODEL/CATALOG NUMBER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE MINI PL-TENSION BAND BRD/3X3H/MALLEABLE/1.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion
MAUDE report 15282752 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.