MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

An evaluation is not possible at this time.The implant has not been returned nor has the identifying part and/or lot number been provided.It is unknown if revision surgery has taken place.Attempts to obtain information have been unsuccessful.Upon the receipt of additional information and/or the suspect implant a follow report will be submitted.

Event Description

Post-op x-rays taken (b)(6) 2017 showed the rods pulled out axially from both polyaxial screws at the s2.The separation occurred although the caps/set screws remain intact.The arsenal fixation system was originally implanted on (b)(6) 2017.

Manufacturer Narrative

On 5/9/2017 - additional information provided by the sales rep.Revision surgery was conducted (b)(6) 2017 to remove and replace the entire arsenal fixation system.The explanted construct is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Manufacturer Narrative

The deep gouging wear patterns found on the explanted set screws are consistent with the complaint description.These wear patterns have been replicated in bench top testing by imparting high impact forces on the rod which pushes the rod through the set screw-rod-pedicle screw interface and results in the deep gouging on the distal surface of the set screw.It was also found in bench top testing that once the set screw experiences these high axial slip forces, the axial load on the set screw holding the rod to the pedicle screw is significantly compromised.Once the axial load on the set screw is affected, it can result in the set screw dissociating from the pedicle screw.Based on review of the explanted product, the wear patterns indicate that the set screw at right s1 did not experience final tightening loads.If the set screw did not undergo final tightening, the full axial compression on the set screw-rod-right s1 screw would not have been realized.If the set screw was not applying the full axial load at right s1, it would be easier for the rod to slip, especially because the location of the failure is at the bottom of a construct ending in the sacral-iliac region where screws typically experience the highest loads because they are exposed to the full moment arm of the construct.Based on this assumption and the analysis of the explanted product, it appears that the axial slip failure at right s1 occurred first, which pulled the rod partially through left s1.As the construct was continually fatigued, the set screw at left s1 began to rotate out of the s1 pedicle screw resulting in the thru hole and spiral gouging wear patterns.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 6550039
• MDR Text Key: 74741921
• Report Number: 2027467-2017-00026
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2017

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
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/06/2017
• Supplement Dates Manufacturer Received: Not provided; 04/12/2017
• Supplement Dates FDA Received: 06/02/2017; 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other