MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802750
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device disposed.
Event or Problem Description
It was reported that an es2 integrated blade polyaxial screw was found fractured at the tab and disengaged intra-operatively during a planned revision for extension.
Event or Problem Description
It was reported that an es2 integrated blade polyaxial screw was found fractured at the tab and disengaged intra-operatively during a planned revision for extension.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history was performed and no relevant manufacturing issues were identified as all units met stryker specifications.A review of complaint history records was performed, and no similar complaints were identified.Per surgical technique: insert the rod percutaneously from either the most cephalad or caudal screw through the blades.Guide the rod through each pair of blades.Important note: do not mallet the rod inserter.Note: the opening of the ring at the most cephalad screw should be oriented in the cephalad direction and the opening of the ring at the most caudal screw should be oriented in the caudal direction.The rod is to be inserted from the open side of the ring.Note: ensure that the rod overhangs the last screw head to allow for secure fixation.Also, the hex end of the rod should not be within the first screw head.Note: the positioning of the rod between the blades can be visualized directly or with fluoroscopic imaging or using the rod length/passage indicator.It was reported that the doctor noted that poor bone quality and excessive force could have led to screw migration.Most likely the event occurred due to excess cantilever or torsional force applied during rod placement/adjustment due to poor bone quality of patient.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9742220
• Report Number: 0009617544-2020-00025
• Device Sequence Number: 13907048
• Product Code: NKB
• UDI-Device Identifier: 07613327002027
• UDI-Public: 07613327002027
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482802750
• Device Catalogue Number: 482802750
• Device Lot Number: 197390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR