MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482802880
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2016, th9 - s2ai were fixed.L2 and l3 pso was performed.During final confirmation with x-ray, the deviation of right s2ai screw head was found.The surgeon exchange the screw and finished the surgery.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; per email correspondence with the sales rep, the blocker was being final tightened when the issue was noticed.Deformations on the returned tulip head indicates that too much force was applied to the screw.According to the risk file, too much force applied to bone screw may cause tulip separation, resulting in placing new screw.It is likely the probable root cause is likely that the reported event of tulip separation took place due to excessive force applied on the screw.
Event or Problem Description
It was reported that on (b)(6) 2016, th9 - s2ai were fixed.L2 and l3 pso was performed.During final confirmation with x-ray, the deviation of right s2ai screw head was found.The surgeon exchange the screw and finished the surgery.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5945711
• Report Number: 0009617544-2016-00364
• Device Sequence Number: 680524
• Product Code: NKB
• UDI-Device Identifier: 07613327002546
• UDI-Public: (01)07613327002546
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482802880
• Device Lot Number: 140636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 63