MAUDE Adverse Event Report: ALPHATEC SPINE INC TI ALLOY PRECONTOURED ROD 5.5 DIA X 50MM (TI-6AL-4V); PEDICLE SCREW SPINAL SYSTEM

Model Number	62003-05
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zodiac pre-contoured rod is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Revision surgery took place on (b)(6) 2016 to extend an existing zodiac construct at the l4/5 vertebral body to l2 thru the l5.The extension was being performed because the upper non-superior segment facet joint violation had been confirmed.During the case, the existing single level rod was found to be fractured and broke.The zodiac degenerative spine fixation system was originally implanted on (b)(6) 2015.
Additional Manufacturer Narrative
An evaluation of the suspect device revealed no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released in accordance with design specifications.Examination of the fractured rod revealed characteristic pairs of notches at the locations where the set screw had contacted the rod during final tightening; the rod failure propagated from one of the medial set screw notches (no information was given on the level at which the rod fracture occurred).In this case, since the revision surgery was conducted because a facet joint violation had been confirmed, it appears feasible that the facet joint violation placed unusual loads on the construct.This, coupled with the evidence of stress risers due to the notching from the set screw tightening likely led to the failure of the rod.The rod failure was only visible upon removal of the construct.It also seems likely that the rod failure had no effect on the overall performance of the construct.Had the rod fracture led to significant instability, the fractured rod sections would have been out of alignment, which indicates that the surgical site was likely stable at the time of the rod fracture.

• Brand Name: TI ALLOY PRECONTOURED ROD 5.5 DIA X 50MM (TI-6AL-4V)
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5538372
• Report Number: 2027467-2016-00019
• Device Sequence Number: 13671932
• Product Code: KWP
• UDI-Device Identifier: 00844856001824
• UDI-Public: 00844856001824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2016

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: Physician
• Device Model Number: 62003-05
• Device Catalogue Number: 62003-05
• Device Lot Number: 642494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 04/15/2016
• 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: Other