MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 CROSS CONNECTOR 24 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48133024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to lengthen the patients' growing rod, the surgeon noted the end part of the xia 4.5 cross connector which connects to the rod was broken.The surgery was successfully completed using a new connector.No adverse consequences to the patient.
Event or Problem Description
It was reported that during a procedure to lengthen the patients' growing rod, the surgeon noted the end part of the xia 4.5 cross connector which connects to the rod was broken.The surgery was successfully completed using a new connector.No adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection confirmed that the returned cross connector was fractured.Device and complaint history records were reviewed for the reported lot number and no relevant manufacturing issues or similar complaints were identified.Per instruction for use: once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidate.While the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo.Adverse effects may necessitate reoperation or revision.No complication during initial surgery was reported.Patient did not fall post initial surgery.Bone quality of patient is unknown.Most probable cause of the reported event was determined to be fatigue on construct over time.

• Brand Name: XIA TITANIUM 4.5 CROSS CONNECTOR 24 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8933346
• Report Number: 0009617544-2019-00096
• Device Sequence Number: 328957
• Product Code: NKB
• UDI-Device Identifier: 04546540449283
• UDI-Public: 04546540449283
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 48133024
• Device Lot Number: 115970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 25