MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48233600
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: on (b)(6) 2015, the patient underwent the surgery.After surgery, when the surgeon checked x-ray, the rod was broken(l5-s).Therefore, the patient underwent the revision surgery on (b)(6) 2016.During revision surgery, the surgeon tightened the blocker using the torque wrench.When the surgeon pulled out the torque wrench, the screw head separated(l5 right and il left).Therefore the surgeon changed the screw to another same size screw.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: no further investigation for this event is possible at this time as no devices and insufficient information was received.
Event or Problem Description
It was reported that: on (b)(6) 2015, the patient underwent the surgery.After surgery, when the surgeon checked x-ray, the rod was broken(l5-s).Therefore, the patient underwent the revision surgery on (b)(6) 2016.During revision surgery, the surgeon tightened the blocker using the torque wrench.When the surgeon pulled out the torque wrench, the screw head separated (l5 right and il left).Therefore the surgeon changed the screw to another same size screw.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6118595
• Report Number: 0009617544-2016-00469
• Device Sequence Number: 10878798
• Product Code: MNH
• UDI-Device Identifier: 04546540560735
• UDI-Public: (01)04546540560735
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2017

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 Catalogue Number: 48233600
• Device Lot Number: JLY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1