MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP PROXIMAL TIBIA PLATE14 HOLES/262MM-RIGHT; PLATE,FIXATION,BONE

Model Number	240.046
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unable to be confirmed if cultures were taken or what the results of the cultures were.
Additional Manufacturer Narrative
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 unable to be confirmed if cultures were taken or what the results of the cultures were.

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE14 HOLES/262MM-RIGHT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6668004
• Report Number: 3003506883-2017-10121
• Device Sequence Number: 816588
• Product Code: HRS
• UDI-Device Identifier: 10886982164636
• UDI-Public: (01)10886982164636(10)7552704
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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 Model Number: 240.046
• Device Catalogue Number: 240.046
• Device Lot Number: 7552704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 07/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention