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 Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; plif (l4-5) was performed on (b)(6) 2015.Additional fixation (l5-s1) was performed on (b)(6) 2016.One month after the second surgery, the breakage of s1 screw was found.The revision surgery is not planned at present.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment; the device is still implanted and not returned.Two possible lot numbers were provided.Upon manufacturing history review for both lot numbers, no relevant issues found.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; plif (l4-5) was performed on (b)(6) 2015.Additional fixation (l5-s1) was performed on (b)(6) 2016.1 month after the second surgery, the breakage of s1 screw was found.The revision surgery is not planned at present.

• 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: 5894734
• Report Number: 0009617544-2016-00343
• Device Sequence Number: 13681791
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2016

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: 482802645
• Device Lot Number: 158824 OR 15A665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 65