MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW CANNULATED 6.5 X 30; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	488526530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Numbness (2415)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent an l4 to s1 lumbar fusion on (b)(6) 2018.On (b)(6) 2018 the patient complained of pain and numbness.X-ray showed the rods connecting the l4 to s1 screws had slipped on the s1 screws.Revision surgery was performed.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the submitted medwatch report event was confirmed as "failed hardware." no further information is available regarding this event.The screws were not returned for evaluation therefore product inspection could not be performed.The lot numbers was not provided therefore design history review and complaint history review could not be performed.Conclusion: as the devices were not returned, the x-rays were not provided and no additional information is available about this event, a definite root cause cannot be determined.Potential root caused based on the risk file: screw is placed at a trajectory which creates additional forces on the screw during insertion; extension from previous construct; previous hardware is present in same vb; surgeon applies too much force or not enough force onto the screwdriver; patient's bone is too hard or too soft; screw is not strong enough to withstand driving forces.
Event or Problem Description
Patient underwent an l4 to s1 lumbar fusion on (b)(6) 2018.On (b)(6) 2018, the patient complained of pain and numbness.X-ray showed the rods connecting the l4 to s1 screws had slipped on the s1 screws.Revision surgery was performed.

• Brand Name: POLYAXIAL CORTICAL SCREW CANNULATED 6.5 X 30
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8112637
• Report Number: 0009617544-2018-00280
• Device Sequence Number: 19424123
• Product Code: NKB
• UDI-Device Identifier: 07613327134551
• UDI-Public: 07613327134551
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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 Catalogue Number: 488526530
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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 Weight: 109