MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); NKB, MNI, MNH, OSH

Model Number 47027

Device Problems Detachment Of Device Component (1104); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 04/30/2015

Event Type  Injury  

Event Description

During a scheduled post-op visit x-rays detected four (4) set screws located at the l4-l5 had become detached from both sides of the arsenal construct.The detached set screws allowed both rods to become elevated and no longer secured within the tulip/head of the polyaxial screws.The construct was originally implanted on (b)(6) 2015 and is positioned from the t-11 thru l5 vertebral bodies.Revision surgery was conducted on (b)(6) 2015.The four detached set screws were removed and replaced which compressed and secured both rods back into proper position.

Manufacturer Narrative

An evaluation of the suspect implants is not possible at this time.The identifying lot number(s) have not been provided nor have the set screws been returned for evaluation.Upon the receipt of additional information and/or the return of the explanted set screws, a follow-up report will be submitted.The arsenal spinal fixation system is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications.The arsenal system consists of a variety of shapes and sizes of rods, screws, and connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.The screws and connectors are manufactured from surgical grade titanium alloy (ti-6al-4v eli).The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (cp ti grade 4, ti-6al-4v eli, and co-28cr-6mo).

Manufacturer Narrative

During a scheduled post-op visit x-rays detected two (2) set screws located at the pelvis had become detached from both sides of the arsenal construct.The detached set screws allowed both rods to become elevated and no longer secured within the tulip/head of the polyaxial screws.The construct was originally implanted on (b)(6) 2015 and is positioned from the t-11 thru the pelvis.Revision surgery was conducted on (b)(6) 2015.The detached set screws were both removed and replaced which compressed and secured both rods back into proper position.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Type of Device: NKB, MNI, MNH, OSH
• 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: 4787851
• MDR Text Key: 5801618
• Report Number: 2027467-2015-00074
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• 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
• Report Date: 04/30/2015

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: 47027
• Device Catalogue Number: 47027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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