MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS VITALLIUM ROD 5.5 X 600 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	486613601
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case a rod broke while bending it with the french bender.**update** per email correspondence with the sales rep, it was reported that "the doctor is okay, just frustrated".
Additional Manufacturer Narrative
Method: risk assessment; results: the rep confirmed that there was reverse bending of the rod performed, laser were facing away from the bender, rod broke on the superior end of the rod, long sweeping bend was being performed, rod was not retrieved.Stg states: to contour the rod, a series of small incremental adjustments will bend the rod gradually and help ensure even stress distribution on the rod.Do not contour a bent rod in the opposite direction; bending and unbending the rod." conclusion: the most likely cause of the fracture is too acute bending and rebending of the rod as advised against in the stg.
Event or Problem Description
It was reported that during a case, a rod broke while bending it with the french bender.Update: per email correspondence with the sales rep, it was reported that "the doctor is okay, just frustrated.".

• Brand Name: RADIUS VITALLIUM ROD 5.5 X 600 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: 5628846
• Report Number: 0009617544-2016-00173
• Device Sequence Number: 523430
• Product Code: NKB
• UDI-Device Identifier: 04546540591197
• UDI-Public: (01)04546540591197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2016

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: 486613601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1