MAUDE Adverse Event Report: ALPHATEC SPINE INC OCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II); ROD AND SCREW SPINAL INSTRUMENTATION

Model Number	75000-056
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned occipital plates are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
After placing the rod into the left side of the 56mm avalon plate, set screws were installed and tightened, splaying the "tulip" repeatedly.The plate was removed and another 56mm plate and rescue screws installed.This time, the rod on the left side went in fine but the rod on the right had the same splay issue.In both occurrences it appeared to be the right half of the tulip which splayed.The exchange of occipital plates caused over a 30 minute delay in the case.
Additional Manufacturer Narrative
An evaluation of the of the device history records found no manufacturing, processing or design related irregularities.Both occipital plate assemblies were found to be properly manufactured and released in accordance with the device master record.Testing indicated that the most likely root cause of the failure was non-axial alignment of the set screw to screw body during the insertion/tightening process.While performing posterior occipito-cervical fusion cases, often times the occipital plate is mounted on the occiput of the patient, far inferior and as close to the fixated cervical level as possible, resulting in upwards of a 90° bend in the rod.In most patients, the anatomy of the shoulders can present a difficult approach to directly access the attachment features of the occipital plate.With the avalon plate, there are 3 unique degrees of freedom that allow for movement of the attachment point to the rod.This is intended to help mitigate a sometimes difficult approach.When patient anatomy and/or the extreme contours of the rod cause a straight approach to be difficult, the hexalobe driver can be easily misaligned during set screw placement.When this occurs, the set screw can often become cross threaded causing damage to the plate assembly or the set screw itself.

• Brand Name: OCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II)
• Common Device Name: ROD AND SCREW SPINAL INSTRUMENTATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5980183
• Report Number: 2027467-2016-00074
• Device Sequence Number: 959123
• Product Code: NKB
• UDI-Device Identifier: 00844856068728
• UDI-Public: 00844856068728
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2016

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?: No
• Operator of Device: Physician
• Device Model Number: 75000-056
• Device Catalogue Number: 75000-056
• Device Lot Number: 7821003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 11/14/2016
• 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
• Patient Age: 20 YR