MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon screw insertion l4 pedicle outer side is cracked.L4 was skipped, construct extended to from l3 to l5.There is no allegation of a device malfunction.The major damage to the bone was reported.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the rep.The screw was discarded and the lot number is unknown.Thus, product inspection and device history review could not be completed.For reported screws, tapping is recommended in most cases.For larger diameter screws, there is more torque applied at the upper part of the screw due to the cancellous cortical thread design combined with a dual lead.Under tapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.It is unknown if the surgeon tapped or if under tapping occurred.Conclusion: a definite root cause cannot be determined based on the information provided.Possible root causes include lack of tapping, under tapping, poor bone quality, difficult angle, inadequate alignment with the compressor, screw not placed properly, inadequate screw hole preparation, and/ or patient anatomy/factors.Device not returned.
Event or Problem Description
It was reported that upon screw insertion l4 pedicle outer side is cracked.L4 was skipped, construct extended to from l3 to l5.There is no allegation of a device malfunction.The major damage to the bone was reported.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8048397
• Report Number: 3005525032-2018-00069
• Device Sequence Number: 1625335
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• 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): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482616545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other