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

Catalog Number 47110545

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2016

Event Type  Injury  

Event 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.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5721584
• MDR Text Key: 47289371
• Report Number: 0009617544-2016-00234
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540680570
• UDI-Public: (01)04546540680570
• Combination Product (y/n): N
• PMA/PMN Number: K103292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 47110545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 56