MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482802645
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; no relevant manufacturing issues were identified as all units met specifications.The screw was returned in 2 pieces, the tulip head was disengaged from the main screw body.It is likely that the reported event of tulip separation took place due to excessive force applied in an incorrect location on the screw.
Event or Problem Description
It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6460585
• Report Number: 0009617544-2017-00128
• Device Sequence Number: 16288714
• Product Code: NKB
• UDI-Device Identifier: 07613327001945
• UDI-Public: (01)07613327001945
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 482802645
• Device Lot Number: 165093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR