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

Model Number	47027
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One other set screw with a separate part and lot number was also return for evaluation.(b)(4); lot# 696252 manufactured (b)(6) 2015.The set screws were returned and examined by r&d.It was noted that the underside of the set screws exhibited wear patterns atypical of the type of wear seen on samples which have been subjected to standard locking/final tightening conditions.A series of tests were conducted in an attempt to generate failure of the screw construct and replicate the wear patterns to assign a root cause.All tests were unable to produce a failure of the set screw or construct and were also unable to replicate the wear patterns noted.It therefore appears that the set screw failures may be a result of atypical loading or due to a surgical technique outside the bounds for which the screw was designed.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2016 to remove and replace 3 arsenal set screws at the l5-s1.The set screws were found to have backed out of position one month post-op.The arsenal spinal fixation was originally implanted on (b)(6) 2015.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5457228
• Report Number: 2027467-2016-00012
• Device Sequence Number: 18902832
• Product Code: NKB
• UDI-Device Identifier: 00844856070325
• UDI-Public: 00844856070325
• Combination Product (Y/N): N
• PMA/510(K) Number: K133221
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2016

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: 47027
• Device Catalogue Number: 47027
• Device Lot Number: 692705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2016
• Initial Report FDA Received Date: 02/24/2016
• 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: Hospitalization