MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 HEX STRAIGHT ROD 5.5 X 80MM; UNKNOWN SPINE PRODUCT

Catalog Number	482807080
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2015 4 screws were implanted for l1 right without problem.On (b)(6) 2016 attempted to remove after fused bones of the spine by plan, but a screw had been separated, so couldn't remove it out of patient body.Other 3 screws have been completed to remove.
Additional Manufacturer Narrative
Risk assessment; the implants were implanted for 15 months.Product was not returned and lot# was not provided.The plausible root cause of this event is likely to be fatigue due to the length of implantation.
Event or Problem Description
It was reported that on (b)(6) 2015 4 screws were implanted for l1 right without problem.On (b)(6) 2016 attempted to remove after fused bones of the spine by plan, but a screw had been separated, so couldn't remove it out of patient body.Other 3 screws have been completed to remove.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 80MM
• Common Device Name: UNKNOWN SPINE PRODUCT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6190944
• Report Number: 0009617544-2016-00498
• Device Sequence Number: 16400336
• Product Code: NKB
• UDI-Device Identifier: 07613327001525
• UDI-Public: (01)07613327001525
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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: 482807080
• Device Lot Number: L9N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1