MAUDE Adverse Event Report: STRYKER SPINE-FRANCE BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48850000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It ia reported that the patient is being revised due to a blocker that backed out of a tulip head.The issue was noticed by the surgeon on a regular post op visit.The surgeon indicated the patient heard squeaking of the hardware.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.When functionally inspected, the blocker was able to be threaded into the screw tulip head and held a sample rod in place.A definite root cause of the reported event could not be determined conclusively.
Event or Problem Description
It ia reported that the patient is being revised due to a blocker that backed out of a tulip head.The issue was noticed by the surgeon on a regular post op visit.The surgeon indicated the patient heard squeaking of the hardware.
Additional Manufacturer Narrative
(b)(6).The conclusion of the investigation remains the same and could not be determined conclusively.
Event or Problem Description
It ia reported that the patient is being revised due to a blocker that backed out of a tulip head.The issue was noticed by the surgeon on a regular post op visit.The surgeon indicated the patient heard squeaking of the hardware.

• Brand Name: BLOCKER
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6205911
• Report Number: 0009617544-2016-00505
• Device Sequence Number: 16339688
• Product Code: KWP
• UDI-Device Identifier: 07613327132526
• UDI-Public: (01)07613327132526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/12/2017

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: PBJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 04/21/2017; 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1