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

Catalog Number	481321060
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported a patient complained of clicking in his back; x-ray showed the rod pulled out of bottom screw post operatively.No adverse event to the patient and no plans for a revision at this time.
Additional Manufacturer Narrative
Visual inspection of two post-op x-ray images were provided and evaluated.Images confirmed that the rod disengaged from the bottom screw.Based on the images, it appears that the rod is too short and most likely, the rod was not overhanging the screw 4 mm as indicated in the surgical technique., dimensional, functional inspection, and material analysis could not be performed as the device remains implanted.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.It was confirmed via x-ray that the rod migrated out of the bottom screw post-operatively.No revision surgery is scheduled at this time, no other patient harm has been reported.There were no complications during the original surgery.The date of the surgery is unknown.Patient¿s post op activity level is unknown, unknown if fusion was achieved, patient¿s bone quality is unknown, and unknown if the patient experience a fall, a torque wrench was used to final tighten.Blockers were tightened to 8nm, the screw was not inserted at a difficult angle, the screw holes were prepared with a 4.0 drill, 5.5 mm tap and a screwdriver was used to insert the screws.Short rod placed in the construct, may cause the rod to pull out of tulip post op.In addition, short rod placement may have lead to rod slipping out of the screws.The plausible root cause of the reported event is most likely user error.However without device evaluation this cannot be confirmed.The surgical technique states: "the rod should be cut to the appropriate length with approximately 4 mm of rod overhanging the screw." device remains implanted in patient.
Event or Problem Description
It was reported a patient complained of clicking in his back; x-ray showed the rod pulled out of bottom screw post operatively.No adverse event to the patient and no plans for a revision at this time.

• Brand Name: XIA 4.5 X 60 TITANIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8597938
• Report Number: 0009617544-2019-00071
• Device Sequence Number: 14210599
• Product Code: NKB
• UDI-Device Identifier: 07613327003253
• UDI-Public: 07613327003253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092605
• 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): 07/11/2019

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: 481321060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1