MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MINI PLATE, 16-HOLES (1/P); IMPLANT

Catalog Number	55-10516
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/26/2018
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 unable to be returned for evaluation.
Event or Problem Description
It was reported that the plate broke post-operatively.The patient did not comply with the soft food recommendation following the procedure, and the fractured plate was removed in a revision surgery.

• Brand Name: MINI PLATE, 16-HOLES (1/P)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 9008429
• Report Number: 0008010177-2019-00060
• Device Sequence Number: 13982600
• Product Code: JEY
• UDI-Device Identifier: 04546540356239
• UDI-Public: 04546540356239
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55-10516
• Device Lot Number: 1000262992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52