NA 50-20706Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Bone Screws, MP, Cross-Pin · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34546540602566), received between Mar 25, 2020 and Sep 8, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Loss of Osseointegration1
Patient problems
- Pain2
- Abscess1
- Bacterial Infection1
- Failure of Implant1
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2020Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF SLEEP APNEA AND BLEEDING UNDERWENT A LEFORT 1/BSSO PROCEDURE ON (B)(6) 2020. PATIENT CAME IN FOR FOLLOW UP VISIT COMPLAINING OF SOME PAIN, AND SURGEON NOTICED A CROSS BITE. SURGEON HAD PATIENT SCANNED AND DETERMINED THAT HARDWARE MAY BE LOOSE. SURGEON REMOVED HARDWARE FROM PATIENT¿S RIGHT AND LEFT MANDIBLE, PUT PATIENT IN ARCH BARS TO REESTABLISH OCCLUSION AND FIXATED RIGHT AND LEFT MANDIBLE. PROCEDURE WAS COMPLETED WITH NO ISSUES.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 10504420 ↗InjuryMar 25, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A SURGEON THAT A PATIENT REQUIRED A REVISION SURGERY DUE TO EXPERIENCING PAIN AND HAVING PUS SECRETIONS APPROXIMATELY 4-5 WEEKS AFTER INITIAL IMPLANTATION WITH AN IMPLANT. THE ORIGINAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY, BUT DURING THE REVISION SURGERY IT WAS FOUND THAT THE SCREWS HAD LOOSENED, CALCIFICATION FORMED NEAR THE PLATE, AND A PATIENT SWAB TESTED AS MRSA POSITIVE. THE PLATE WAS REMOVED.
Patient problems: Abscess; Bacterial Infection; Pain
MAUDE report 9877948 ↗
Other PLATE, BONE devices
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- 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 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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