MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 70 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	481322070
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on tuesday november 8th the doctor saw a post op patient in his office.Based on x ray, he feels concerned that the patient has experienced an implant related post op event.In surgeons words, "hardware has appeared to have shifted.Rod seems to have slipped beneath a set screw.".
Additional Manufacturer Narrative
Risk assessment; the device was not sent back for evaluation.No lot # was provided, so a manufacturing record review could not be performed.The root cause could not be determined conclusively because the device is unavailable for evaluation.
Event or Problem Description
It was reported that on tuesday (b)(6) the doctor saw a post op patient in his office.Based on x ray, he feels concerned that the patient has experienced an implant related post op event.In surgeons words, "hardware has appeared to have shifted.Rod seems to have slipped beneath a set screw.".

• Brand Name: XIA 4.5 X 70 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6147574
• Report Number: 0009617544-2016-00483
• Device Sequence Number: 53106
• Product Code: MNH
• UDI-Device Identifier: 07613327002614
• UDI-Public: (01)07613327002614
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K050461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: No Information
• Device Catalogue Number: 481322070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 03/08/2017
• 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: Other