MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number 47127

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

The arsenal set screw is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

Two month post op visit x-rays confirmed the set screw which had been implanted at the right side of the l5 had backed out of position.Revision surgery was conducted (b)(6) 2016 to remove and replace the arsenal implant.The arsenal spinal fixation system was originally implanted (b)(6) 2016.

Manufacturer Narrative

Although the report was for 1 set screw back out at the right side of the l5, the left side was returned as well.Both are of the same manufacturing lot number.A review of the device history records revealed no irregularities.The implants were found to be properly manufactured and released according to design specifications.The wear patterns on the right l5 backed out set screw are not typical of known wear patterns identified on either backed out set screws or ones which have performed as intended.High resolution images revealed damage/wear to the outer perimeter as well as a very faint rod contact markings produced during the final tightening process.The rod contact marking is especially faint on one side of the set screw.The l5 left side set screw shows damage to both the leading thread and the id hexalobe feature.This indicates there may have been some difficulty initially starting the threading process during attachment/union with the pedicle screw.The rod contact marking is also atypical.The damage demonstrates some contact was made but does not indicate clear contact on one side.This indicates that the rod may have been at an angle or in a position which prevented proper contact with the set screw during final tightening process.The provided mri images from the re-operation do not indicate that the rod angle would have been a concern since this is a one-level construct.The re-operation features a rod with very little curvature and straight forward screw angles.However, the construct upon re-operation could be significantly different from the original construct.The markings on the returned set screws indicate uneven loading and atypical damage.Based on the information available, it appears that the uneven loading may have led to insufficient set screw/rod contact resulting in the set screw backing out of the construct.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 5722801
• MDR Text Key: 47322604
• Report Number: 2027467-2016-00037
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: 00840967124582
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

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?: Yes
• Device Operator: Physician
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 696257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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
• Patient Age: 73 YR