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

Model Number 47027

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

No evaluation possible.The identifying lot numbers have not been provided.The explanted construct was given to the patient upon removal.

Event Description

Two arsenal set screws (47027) were found detached from the tulip of the mating polyaxial screws located at both the right and left sides of the s1.The patient was reported to have already fused/healed.Revision surgery was conducted on (b)(6) 2016 to remove the l4-s1 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: 6017885
• MDR Text Key: 57042209
• Report Number: 2027467-2016-00080
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00844856070325
• UDI-Public: 00844856070325
• 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
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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
• Date Manufacturer Received: 09/16/2016
• 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: 47 YR