MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SMARTLOCK HYBRID MMF PLATE, 2/P; IMPLANT

Catalog Number	55-02950
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2017
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.Product was discarded at the user facility.
Event or Problem Description
It was reported by a company representative that a patient had experienced a misaligned occlusion after a procedure.A revision surgery was performed in order to correct the issue.

• Brand Name: SMARTLOCK HYBRID MMF PLATE, 2/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7647896
• Report Number: 0008010177-2018-00067
• Device Sequence Number: 13496750
• Product Code: HRS
• UDI-Device Identifier: 34546540732072
• UDI-Public: 34546540732072
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040022
• 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): 06/28/2018

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: 55-02950
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1