MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802745
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that screw head detached post-operatively.The patient was in pain and underwent revision surgery on (b)(6) 2018.This complaint will be reported as serious injury due to medical intervention.
Additional Manufacturer Narrative
Product return information updated.
Event or Problem Description
It was reported that screw head detached post-operatively.The patient was in pain and underwent revision surgery on (b)(6) 2018.This complaint will be reported as serious injury due to medical intervention.
Additional Manufacturer Narrative
Method: x-ray image review, visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via x-ray images and visual inspection of the returned device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Inspection of the returned device confirmed deformation on the tulip head locking ring and on the head of the screw shank.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.Deformation on the screw shank also indicate over-angulation of the screw.However, a review of the x-ray images did not reveal over-angulation on the screw.Conclusion: the root cause of the reported event could not be determined conclusively but it is likely that the screw tulip head disengaged due to blocker over-tightening, poor bone quality or patient experienced fall/trauma.
Event or Problem Description
It was reported that screw head detached post-operatively.The patient was in pain and underwent revision surgery on (b)(6) 2018.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8146638
• Report Number: 0009617544-2018-00293
• Device Sequence Number: 1961188
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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,Followup
• Report Date (Section B): 03/18/2019

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: 482802745
• Device Lot Number: 183975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/26/2018; 02/21/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/24/2019; 03/18/2019
• 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 Age: 67 YR
• Patient Weight: 96