MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 6.5 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	488516535
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 2 screws pulled out of vertebral body and interbody cage migrated from original position.Patient required revision surgery.
Additional Manufacturer Narrative
Method: risk assessment.Result: the event was confirmed based communication with sales representative.The screw was removed but not replaced and are unavailable for evaluation.X-rays were not provided.The lot number is unknown, thus, a manufacturing records review could not be completed.Conclusion: as the device and x rays are not available, a definite root cause cannot be identified.It is possible the screw was placed too proud in the bone, which could reduce bone purchase and cause pullout.Patient bone quality could also be a factor as poor bone quality can affect screw purchase.Device not returned.
Event or Problem Description
It was reported that 2 screws pulled out of vertebral body and interbody cage migrated from original position.Patient required revision surgery.

• Brand Name: POLYAXIAL CORTICAL SCREW 6.5 X 35
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7573024
• Report Number: 0009617544-2018-00133
• Device Sequence Number: 16699598
• Product Code: NKB
• UDI-Device Identifier: 07613327134667
• UDI-Public: (01)07613327134667
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: Health Professional
• Device Model Number: 488516535
• Device Catalogue Number: 488516535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: 58 YR