MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the postoperative cage migrated and removed the cage by reoperation.The right pedicle broke, as a result of broken bone, l4 the screw on the right was loose and re-locked by changing the screw insertion direction.
Additional Manufacturer Narrative
Nc/capa history review, labelling review, risk assessment the customer reported event was confirmed via correspondence with the rep.It was reported that a screw migrated out of position after surgery due to a broken pedicle.The screw was not returned for evaluation and the lot number is unknown so manufacturing record review could not be performed.It was reported that the pedicle was cracked that led to the screw being out of position.No complications were noted in the initial surgery so it is most likely that the pedicle cracked after the initial surgery and before the revision surgery.It is unknown what could have caused the pedicle fracture as the patient's post op activity is unknown, it is unknown what the patient's bone quality is, and no patient information/x rays were provided.It is unknown how the screw holes were prepared and if this had any effect on the pedicle cracking post operatively.The most likely root cause for screw migration is the pedicle cracking causing the screw move post operatively, however there is not enough information available to determine what caused the pedicle breakage.Patient post op activity, poor bone quality, disease, and/or screw hole preparation could have all caused or contributed to the pedicle breaking.
Event or Problem Description
It was reported that the postoperative cage migrated and removed the cage by reoperation.The right pedicle broke, as a result of broken bone, l4 the screw on the right was loose and re-locked by changing the screw insertion direction.

• Brand Name: 6.5X40 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7974732
• Report Number: 3005525032-2018-00067
• Device Sequence Number: 1578361
• Product Code: NKB
• UDI-Device Identifier: 07613327351958
• UDI-Public: 07613327351958
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• 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): 01/31/2019

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: Health Professional
• Device Catalogue Number: 482616540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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