MAUDE Adverse Event Report: ORTHOFIX INC. FORZA PTC SPACER SYSTEM; STRAIGHT PTC IMPLANT

Model Number	38-3011SP
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that patient was implanted with forza ptc spacer and non-orthofix screw and rods.Approximately one (1) month post-op, x-rays revealed that the spacer was backing out.Patient became symptomatic in january and it was noticed via x-rays that spacer was impinging on nerves.Revision surgery was performed in march to replace straight ptc spacer with curved ptc spacer.

• Brand Name: FORZA PTC SPACER SYSTEM
• Common Device Name: STRAIGHT PTC IMPLANT
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6714928
• Report Number: 2183449-2017-00020
• Device Sequence Number: 1236770
• Product Code: MAX
• UDI-Device Identifier: 18257200091928
• UDI-Public: 18257200091928
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: Physician
• Device Model Number: 38-3011SP
• Device Lot Number: 001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR