MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO TRAUMA SCREW DIA 5.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	47110545
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the primary surgery for l1 burst fracture was performed on (b)(6) 2015.After that the screw fracture on l2 left was found and the extraction surgery of all implant was performed.The tip of the fractured screw was left in the patient.
Additional Manufacturer Narrative
Risk assessment; manufacturing files could not be reviewed because not lot or parts were returned.The actual root cause cannot be determined due device not being returned and lack of information,.
Event or Problem Description
It was reported that the primary surgery for l1 burst fracture was performed on (b)(6) 2015.After that the screw fracture on l2 left was found and the extraction surgery of all implant was performed.The tip of the fractured screw was left in the patient.

• Brand Name: TRIO TRAUMA SCREW DIA 5.5 X 45 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: 5721584
• Report Number: 0009617544-2016-00234
• Device Sequence Number: 857
• Product Code: NKB
• UDI-Device Identifier: 04546540680570
• UDI-Public: (01)04546540680570
• Combination Product (Y/N): N
• PMA/510(K) Number: K103292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 47110545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Weight: 56