MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, STRAIGHT, 24 HOLE, MIDFACE; IMPLANT

Model Number	55-06724
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device not available for return.
Event or Problem Description
It was reported by the company representative that the patient experienced non-union/infection of the bone where the plate was implanted.A revision surgery was completed to remove the plate.

• Brand Name: PLATE, STRAIGHT, 24 HOLE, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 10267639
• Report Number: 0008010177-2020-00036
• Device Sequence Number: 3439974
• Product Code: JEY
• UDI-Device Identifier: 04546540365958
• UDI-Public: 04546540365958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 55-06724
• Device Catalogue Number: 55-06724
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1