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 No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been returned for evaluation nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

Three (3) months post op x-rays revealed the bottom set screws of a 7-level fusion had come loose.Revision surgery was conducted on (b)(6) 2016 to remove and replace the set screws located at t7 and t8 thoracic vertebrae's.

• 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: 6057965
• MDR Text Key: 58412317
• Report Number: 2027467-2016-00082
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: 00840967124582
• 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: 09/30/2016

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?: 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
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/26/2016
• 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: 44 YR