MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rod broke when the doctor was trying to bend it.There are no reports of adverse consequences to the patient.There was a 10 minute surgical delay associated with the event.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the rep.The device was not returned for evaluation as it could not be located at the site.Manufacturing records review could not be performed as the lot number is unknown.Conclusion: as the device was not returned, a definite root cause cannot be determined.Possible root causes include rod not properly aligned and user applies too much compressive force.
Event or Problem Description
It was reported the rod broke when the doctor was trying to bend it.There are no reports of adverse consequences to the patient.There was a 10 minute surgical delay associated with the event.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7804323
• Report Number: 3005525032-2018-00051
• Device Sequence Number: 1574042
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: 04546540608642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 48232601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1