MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 8.5X70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804870
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient came in with pain.The tulip of the screw broke apart and revision surgery was performed.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the screw was returned in 2 pieces as the tulip head was disengaged from the screw shank.There was deformation on the tulip head locking ring and on the head of the screw shank.Deformation of the screw shank indicates that the rod was seated.Deformation of tulip head locking ring indicates that the screw shaft was pressing against deformed side of the tulip head likely due to over angulation on screw, causing the screw shank to disengage.Manufacturing history was reviewed and no issues were identified.Conclusion: due to lack of information, the root cause of the reported event could not be determined conclusively but based on inspection of the returned products, it is likely that the screw tulip head disengaged due to over-angulation of the screw.Potential contributing factors include: blocker over-tightening, poor bone quality or excessive post-op activity level of the patient.
Event or Problem Description
It was reported that the patient came in with pain.The tulip of the screw broke apart and revision surgery was performed.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 8.5X70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7455562
• Report Number: 0009617544-2018-00087
• Device Sequence Number: 19148437
• Product Code: NKB
• UDI-Device Identifier: 07613327002508
• UDI-Public: (01)07613327002508
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: No Information
• Device Model Number: 482804870
• Device Catalogue Number: 482804870
• Device Lot Number: 152446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 110