MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482802650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; on (b)(6) 2016, es2 surgery for l2/3 burst fracture was performed.T12-l5 were fixed, l2 were skipped.After the surgery, the breakage of both side l5 screw was found.All the implant were extracted on (b)(6) 2016 because the fracture has healed.The tips of the broken screws were remained to the patient.Update: patient was fused.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the fractured portion of the screw remains implanted and the removed portion was not returned at the time this complaint was closed.Upon manufacturing history review, no relevant issues found.Conclusion: due to the absence of device for evaluation and lack of sufficient information, the root cause of this event cannot be determined conclusively, and it therefore multifactorial.
Event or Problem Description
It was reported that; on (b)(6) 2016, es2 surgery for l2/3 burst fracture was performed.T12-l5 were fixed, l2 were skipped.After the surgery, the breakage of both side l5 screw was found.All the implant were extracted on (b)(6) 2016 because the fracture has healed.The tips of the broken screws were remained to the patient.Update: patient was fused.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5957731
• Report Number: 0009617544-2016-00366
• Device Sequence Number: 18985486
• Product Code: MNI
• UDI-Device Identifier: 07613327001952
• UDI-Public: (01)07613327001952
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2016

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: 482802650
• Device Lot Number: 14D174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR