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

Model Number 47127

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implants have not been removed from the patient nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

X-rays taken approximately 5 months post-op showed the arsenal set screws located at both the l4 and l5 had backed out of position.The patient is asymptomatic and there are currently no plans for revision.The two level posterior fixation with expandable interbody was inserted at the l4 - s1.

• 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: 7087081
• MDR Text Key: 94814785
• Report Number: 2027467-2017-00089
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• 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): Other