MAUDE Adverse Event Report: STRYKER SPINE-FRANCE POLYAXIAL CORTICAL SCREW 5.0 X 35; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	488515035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw head popped off when placing the post in the screw head for distraction.Was able to remove screw shaft and replace screw.
Additional Manufacturer Narrative
Method: risk assessment; result: the customer reported event of a polyaxial screw tulip disengagement was confirmed via correspondence with the sales representative.The screw was discarded at the hospital and the lot number is unknown.As the device, lot information, or x rays/pictures are unavailable, the root cause could not be determined.
Event or Problem Description
It was reported that; screw head popped off when placing the post in the screw head for distraction.Was able to remove screw shaft and replace screw.

• Brand Name: POLYAXIAL CORTICAL SCREW 5.0 X 35
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7112612
• Report Number: 0009617544-2017-00435
• Device Sequence Number: 781165
• Product Code: KWP
• UDI-Device Identifier: 07613327134179
• UDI-Public: (01)07613327134179
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 488515035
• Device Catalogue Number: 488515035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1