MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804650
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: device discarded by the hospital.
Event or Problem Description
The surgeon notified stryker of a revision which took place (b)(6) 2019 to replace a broken es2 integrated blade screw implanted at 4-1 level.
Event or Problem Description
The surgeon notified stryker of a revision which took place on (b)(6) 2019 to replace a broken es2 integrated blade screw implanted at 4-1 level.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analyses could not be performed because the device was disposed of by the hospital.Manufacturing records and device history records were reviewed for the corresponding lot and no relevant issues were identified.No complication was noted during the initial surgery, the patient had good bone quality, and excessive force was not applied by surgeon.The patient's post-operative activity is unknown.The patient did not fuse.During revision surgery the distal half of screw could not be explanted and remains implanted in the patient with no reported adverse consequence.From the es2 surgical technique, "internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture." the patient was not fused fifteen months after the initial surgery.The root cause of reported es2 screw fracture is likely delayed union or non-union which lead to excessive and repeated stresses on the device.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8811604
• Report Number: 0009617544-2019-00089
• Device Sequence Number: 2657605
• Product Code: NKB
• UDI-Device Identifier: 07613327002195
• UDI-Public: 07613327002195
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 482804650
• Device Lot Number: 17E090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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