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 Code	Injury (2348)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that during routine follow-up, one month after implantation, a ct image confirmed that an es2 integrated blade screw tulip, size s 7.5mm, disengaged post-operatively.Revision surgery anticipated but not yet scheduled.This record represents 2 of 2 screws.
Additional Manufacturer Narrative
Visual, dimensional, functional, and material analysis could not be performed as the device remains implanted in the patient.Device and complaint history records were reviewed no relevant issue or similar events were identified.No revision surgery is planned as bone fusion had begun in patient.While the expected life of spinal implant components is difficult to estimate, it is finite.Due to many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Since the device was not returned, root cause of the reported event could not be determined conclusively but may have occurred due to blocker over-tightening or over-angulation on screw during initial surgery.
Event or Problem Description
It was reported that during routine follow-up, one month after implantation, a ct image confirmed that an es2 integrated blade screw tulip, size s 7.5mm, disengaged post-operatively.Revision surgery anticipated but not yet scheduled.This record represents 2 of 2 screws.

• 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: 8826712
• Report Number: 0009617544-2019-00092
• Device Sequence Number: 2687899
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 190314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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: 85 YR