MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802740
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
In the initial surgery performed on (b)(6) 2016, screws were implanted for adult spinal deformity disease.The revision surgery performed on (b)(6) 2018 was carried out against loosening of l6 and s1 of screws.Screws were replaced.
Additional Manufacturer Narrative
Method: risk assessment.Result: the reported event was confirmed via communication with the sales representative.No lot number was provided so manufacturing record review could not be performed.Initial surgery was performed on (b)(6) 2016 and screw loosening was reported on (b)(6) 2018.Conclusion: based on information provided the most likely root cause of the reported event is too much load on the implant overtime what could result in screw purchase compromise.Additional contributing factors could be poor bone quality, patient pathology or excessive post-op activity level.
Event or Problem Description
In the initial surgery performed on (b)(6) 2016, screws were implanted for adult spinal deformity disease.The revision surgery performed on (b)(6) 2018 was carried out against loosening of l6 and s1 of screws.Screws were replaced.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7506199
• Report Number: 0009617544-2018-00109
• Device Sequence Number: 16526165
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: (01)07613327002003
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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: 482802740
• Device Catalogue Number: 482802740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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