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

Model Number 47127

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The user facility has not released the implants.Upon the receipt of additional information and/or the return of the implants a follow-up report will be submitted.

Event Description

Three (3) weeks post-op x-rays revealed the rods at the distal end of a long construct in a patient with marfan syndrome, had slip from heads of the pedicle screws.During the revision ((b)(6) 2018), both the right and left l4 set screws were found to be loose.Both loose set screws remained attached within the heads of the polyaxial screws.The arsenal spinal fixation system was originally implanted on (b)(6) 2018 at the t2 thru l4 to correct a 50-60° curve.

• 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 younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7522634
• MDR Text Key: 108547973
• Report Number: 2027467-2018-00026
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• 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
• Patient Age: 14 YR