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

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records revealed no manufacturing or processing related irregularities.The avalon occipital plate was found to be properly manufactured and released in accordance with design specifications.No evaluation possible at this time.The international customer has not returned the explanted construct.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

After setting the rod on bushing of occipital bone plate, the doctor installed avalon set screws.Both of the bushings were widened by the installation and set screws could not be tightened.

Manufacturer Narrative

An examination of the explanted hardware identified damage to both the occipital plate and mating set screws.The id of the set screws contain markings and deviations to the manufactured hexalobe form.The evidence indicates the torque driver may not have been properly aligned which can prevent the driver from completely engaging with the mating set screw.Additionally, there is damage to the od threads indicative of cross threading.The rotating body/tulip of the occipital plate was found to be splayed and contain damage/voids to the internal threads.The print calls out for the distance from tulip to tulip to be.162 +/-.002.The splay measured between.166 on one tulip and.175 on the other.The investigation concluded the most likely cause of this event was non-axial alignment of the set screw to rotating body/tulip during the insertion/tightening process.When performing posterior occipito-cervical fusion cases, often times the occipital plate is mounted far inferior and as close to the fixated cervical level as possible, resulting in upwards of a 90° bend in the rod.This can present a difficult approach.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 sometime become misaligned during set screw placement.When this occurs, the set screw can become cross threaded causing damage to the plate assembly and/or the set screw.

• Brand Name: OCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II)
• Type of Device: ROD AND SCREW SPINAL INSTRUMENTATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8331516
• MDR Text Key: 137866137
• Report Number: 2027467-2019-00005
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00844856068728
• UDI-Public: (01)00844856068728(10)8047401
• Combination Product (y/n): N
• PMA/PMN Number: K111076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75000-056
• Device Catalogue Number: 75000-056
• Device Lot Number: 8047401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Date Manufacturer Received: 01/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR