MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UN3 DOUBLE-Y PLATE, 6-HOLE, W/BAR; IMPLANT

Model Number	53-34608
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device not available to stryker for evaluation, and no explanation was provided.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after a procedure with an implant.There are no additional details available at this time.
Additional Manufacturer Narrative
The devices were not returned for evaluation and infection documents (i.E.Laboratory test results) have not been received.Thus, the reported event could not be confirmed.For infection complaints expanded investigations are performed to assure that neither the complained device nor all related manufacturing process steps have caused or contributed to the reported event.All results were documented within the ¿infection complaints - checklist investigator¿ (cmfqf 13-002).No discrepancies were found.To gain more information about the complained event the ¿infection complaints _ checklist customer¿ (cmfqf 13-003) was forwarded to the sales rep.It was stated that the surgeon has told the sales rep in person in a follow up meeting that he doesn't believe the plating system has caused the infection.No further information can be provided.Infection is a known adverse event related to this procedure.It has been documented in the instructions for use associated with this device that this type of adverse event may rather be clinically related than implant related.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.Should further information be available, the investigation will be re-evaluated.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after a procedure with an implant.There are no additional details available at this time.

• Brand Name: UN3 DOUBLE-Y PLATE, 6-HOLE, W/BAR
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10173419
• Report Number: 0008010177-2020-00031
• Device Sequence Number: 17044030
• Product Code: GWO
• UDI-Device Identifier: 04546540684783
• UDI-Public: 04546540684783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112557
• 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,Followup
• Report Date (Section B): 04/19/2021

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: Health Professional
• Device Model Number: 53-34608
• Device Catalogue Number: 53-34608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 04/19/2021
• 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