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

Catalog Number	48233600
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; on (b)(6) 2014,(th10-s2ai) surgery was performed.After that, the breakage of the both side rod at under l4 was found.The mac was also broken at l5/s1 and the screw was also broken at left sai.So the revision surgery was performed on (b)(6) 2016, at l4/5 was done.The spinal deformity of the patient was terrible.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The product was not returned for inspection.Conclusion: the root cause of the event could not be determined with the given information.
Event or Problem Description
It was reported that; on (b)(6) 2014,((b)(4)) surgery was performed.After that, the breakage of the both side rod at under l4 was found.The mac was also broken at l5/s1 and the screw was also broken at left sai.So the revision surgery was performed on (b)(6) 2016, at l4/5 was done.The spinal deformity of the patient was terrible.

• 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: 5680353
• Report Number: 0009617544-2016-00209
• Device Sequence Number: 18935739
• Product Code: MNH
• UDI-Device Identifier: 04546540560735
• UDI-Public: (01)04546540560735
• Combination Product (Y/N): N
• 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): 01/04/2017

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: 48233600
• Device Lot Number: CBH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 01/04/2017
• 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: 79 YR