MAUDE Adverse Event Report: ORTHOFIX INC. FORZA PTC; CURVED PTC IMPLANT, STERILE

Model Number	38-1711SP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided, via medwatch report 5069314, states displacement of the forza ptc spacer from the disc and migrated into spinal canal requiring revision surgery.

• Brand Name: FORZA PTC
• Common Device Name: CURVED PTC IMPLANT, STERILE
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6586098
• Report Number: 2183449-2017-00016
• Device Sequence Number: 106231
• Product Code: MAX
• UDI-Device Identifier: 18257200092222
• UDI-Public: 18257200092222
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K103111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 38-1711SP
• Device Lot Number: 001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/23/2017
• 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