MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48230141
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Device remains implanted in patient.
Event or Problem Description
It was reported that a patient originally had an l3-s1 fusion and was brought back for an extension of metal work procedure back in (b)(6) 2018.The patient's l3 screws were removed and the surgeon put 2 more screws into l2 and connected the existing rods to 2 new rods with 2 side to side connectors.They were hand tightened as per surgical technique.The patient has come back for a follow up (completely asymptomatic) and an x-ray indicated that the connector has become loose and slid down the rod and rotated.No surgery is planned currently.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: x-ray review, nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via x rays.Rod has moved but hasn't disengaged from the connector.This was shown in the x rays as the right side connector has slid down the rod and appeared to have rotated.The device still remained implanted in the patient and lot # was not provided, therefore product history review could not be performed.Conclusion: as the device has not been returned a definite root cause cannot be determined.Possible root causes include surgeon over torqueing or under torqueing the blockers, damaged blockers on the connector, and/or excessive post op activity.Device still remained implanted in the patient.
Event or Problem Description
It was reported that a patient originally had an l3-s1 fusion and was brought back for an extension of metal work procedure back in (b)(6) 2018.The patient's l3 screws were removed and the surgeon put 2 more screws into l2 and connected the existing rods to 2 new rods with 2 side to side connectors.They were hand tightened as per surgical technique.The patient has come back for a follow up (completely asymptomatic) and an x-ray indicated that the connector has become loose and slid down the rod and rotated.No surgery is planned currently.There are no reports of adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7931881
• Report Number: 3005525032-2018-00066
• Device Sequence Number: 1311637
• Product Code: NKB
• UDI-Device Identifier: 04546540602312
• UDI-Public: 04546540602312
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: Health Professional
• Device Catalogue Number: 48230141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1