MAUDE Adverse Event Report: STRYKER SPINE-FRANCE BLOCKER; PEDICLE SCREW SPINAL SYSTEM

Model Number	48850000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; revision l3-l5 after rods slipped out of screws.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection and x-ray images.No manufacturing issues were identified.A root cause of the event is overloading on one side of the blocker due to the blocker not being optimally seated on the rod.
Event or Problem Description
It was reported that; revision l3-l5 after rods slipped out of screws.

• Brand Name: BLOCKER
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6775529
• Report Number: 0009617544-2017-00304
• Device Sequence Number: 19209558
• Product Code: MNI
• UDI-Device Identifier: 07613327132526
• UDI-Public: (01)07613327132526
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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 Model Number: 48850000
• Device Catalogue Number: 48850000
• Device Lot Number: SAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91