MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03820645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw was found broken post operatively.The patient had spinal fusion surgery two and a half years ago.Patient was revised to remove the fractured screw.
Additional Manufacturer Narrative
Method: risk assessment; result: the reported event was confirmed via correspondence with the sales rep.The device was not returned, so inspection could not be performed.Two lot numbers were provided by complainant, but it is unknown which lot fractured.Conclusion: as the device was not returned, a definite root cause cannot be determined.Per the ifu the device may have fractured due to fatigue.According to the xia ii ifu, "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 postoperative 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 consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.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, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.".
Event or Problem Description
It was reported that a screw was found broken post operatively.The patient had spinal fusion surgery two and a half years ago.Patient was revised to remove the fractured screw.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7597826
• Report Number: 3005525032-2018-00038
• Device Sequence Number: 205056
• Product Code: NKB
• UDI-Device Identifier: 04546540148919
• UDI-Public: (01)04546540148919
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• 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): 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 03820645
• Device Catalogue Number: 03820645
• Device Lot Number: B02185/B03697
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR