MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 60 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	481322060
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod has slipped through the tulip heads.Original case was on (b)(6).Implants still in patient.Planning on revision.
Additional Manufacturer Narrative
Method:risk assessment; results: visual, dimensional and functional analysis could not be performed as the device was not returned.Device history could not be performed as a valid lot code was not provided.Conclusion: the definitive root cause cannot be determined from the given information.
Event or Problem Description
It was reported that the rod has slipped through the tulip heads.Original case was on 6/20.Implants still in patient.Planning on revision.

• Brand Name: XIA 4.5 X 60 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: 6147685
• Report Number: 0009617544-2016-00485
• Device Sequence Number: 877121
• Product Code: MNH
• UDI-Device Identifier: 07613327003390
• UDI-Public: (01)07613327003390
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/06/2017

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: 481322060
• 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: 06/06/2017
• 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
• Patient Weight: 98