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

Model Number 47127

Device Problem Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been removed from the patient.A review of the device history records revealed no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released according to design specifications.

Event Description

An international customer (b)(6) reported that one month post-op x-rays revealed an arsenal set screw and a novel cage had backed-out of position at the l3.The cage moved near the rod and a lot of the grafted bone fragments entered the spinal canal.At the current moment, no health injury of the patient was confirmed by this incident.

• 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: 5434059
• MDR Text Key: 38777262
• Report Number: 2027467-2016-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2016

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
• Device Lot Number: 695627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• 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
• Patient Age: 71 YR