MAUDE Adverse Event Report: SYNTHES GMBH TI PSPC MATRIXMANDIBLE DOUBLE ANGLE RECON PL/MED/2.5MM THICK; PLATE, BONE

Model Number	SD449.513B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on an unknown date that the implant had to be removed due to infection.The original implantation date was unknown.The procedure and patient outcome were unknown.No other information provided.This report is for one (1) ti pspc matrixmandible double angle recon pl/med/2.5mm thick.This is report 1 of 2 for (b)(4).

• Brand Name: TI PSPC MATRIXMANDIBLE DOUBLE ANGLE RECON PL/MED/2.5MM THICK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11225520
• Report Number: 8030965-2021-00608
• Device Sequence Number: 17017662
• Product Code: JEY
• UDI-Device Identifier: 10887587004839
• UDI-Public: (01)10887587004839
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2021

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: SD449.513B
• Device Catalogue Number: SD449.513B
• Device Lot Number: 83P4339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2021
• Initial Report FDA Received Date: 01/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention