MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO TRAUMA SCREW DIA 5.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	47110550
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; primary surgery was performed for l1 burst fracture on (b)(6) 2014.Th12 and l2 were fixed with screws, l1 were skipped.After that, the fracture was fused and an extraction surgery was performed on (b)(6) 2016.During the surgery, the breakage of l2 left screw was found.The tip of the broken screw was remained to the patient.And then, the set screw hex of l2 right connector worn when the surgeon tried to remove it.Finally, the surgeon destroyed the connector and removed it.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection of the device showed that screw was fractured.The screw was fractured at the threading and the fractured piece was not returned.Conclusion: the definitive root cause of the event could not be determined from the given information.
Event or Problem Description
It was reported that; primary surgery was performed for l1 burst fracture on (b)(6) 2014.Th12 and l2 were fixed with screws, l1 were skipped.After that, the fracture was fused and an extraction surgery was performed on (b)(6) 2016.During the surgery, the breakage of l2 left screw was found.The tip of the broken screw was remained to the patient.And then, the set screw hex of l2 right connector worn when the surgeon tried to remove it.Finally, the surgeon destroyed the connector and removed it.

• Brand Name: TRIO TRAUMA SCREW DIA 5.5 X 50 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5796883
• Report Number: 0009617544-2016-00290
• Device Sequence Number: 13539626
• Product Code: MNH
• UDI-Device Identifier: 04546540680587
• UDI-Public: (01)04546540680587
• Combination Product (Y/N): N
• PMA/510(K) Number: K103292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2016

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: 47110550
• Device Lot Number: 68378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR