MAUDE Adverse Event Report: STRYKER SPINE-US 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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; rods on both sides moved.The blockers stayed within the tulip heads.We put in new rods and new blockers.
Additional Manufacturer Narrative
Risk assessment visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause cannot be determined from the given information.
Event or Problem Description
It was reported that; rods on both sides moved.The blockers stayed within the tulip heads.We put in new rods and new blockers.

• 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-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6384222
• Report Number: 0009617544-2017-00074
• Device Sequence Number: 19079362
• Product Code: MNH
• UDI-Device Identifier: 07613327002614
• UDI-Public: (01)07613327002614
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 61