NA SD480.112Recalls & reported problems
Synthes GmbH · TI PATIENT SPECIFIC PLATE MANDIBLE/ W/O ANGLE/2.0MM THK · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587005348), received between Jan 11, 2021 and Jun 17, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI PS PL MANDBL/ O ANG/2.0 THK. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 12018487 ↗InjuryJan 11, 2021Defective Device; Defective Device
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THAT NEITHER OF THE LEFT OR RIGHT OF THE PATIENT-SPECIFIC MANDIBLE PLATE FIT THE BONE DEFICIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER THE IMPLANTS WERE NOT IMPLANTED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TI PATIENT SPECIFIC PLATE MANDIBLE/ W/O ANGLE/2.0MM THK. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11147008 ↗InjuryJan 11, 2021Defective Device; Defective Device
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THAT NEITHER OF THE LEFT OR RIGHT OF THE PATIENT-SPECIFIC MANDIBLE PLATE FIT THE BONE DEFICIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER THE IMPLANTS WERE NOT IMPLANTED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TI PATIENT SPECIFIC PLATE MANDIBLE/ W/O ANGLE/2.0MM THK. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11146997 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- 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 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.
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