MAUDE Adverse Event Report: ALPHATEC SPINE INC TI POLYAXIAL PEDICLE SCREW - 6.5 MM X 35 MM (TI-6AI-4V ELI); PEDICLE SCREW SPINAL SYSTEM

Model Number 62065-35

Device Problems Bent (1059); Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible.The device has not been removed from the patient nor has the identifying lot number(s) been provided.Alphatec informed the patient that alphatec is a medical device manufacturer and cannot provide any medical advice.We strongly suggest he consult his physician for medical guidance.

Event Description

Patient called alphatec directly and reported that he had surgery in which alphatec products were installed in his back.Two of the screws broke and two of the screws bent.The alphatec zodiac spinal fixation system was implanted in 2014 at the l3 thru s1.X-rays taken approximately one year post-op revealed the two screws located at the s1 had fractured and broke and the two at the l5 had bent.The patient indicated that he is currently not a candidate for revision surgery as he is (b)(6) and in poor health.

• Brand Name: TI POLYAXIAL PEDICLE SCREW - 6.5 MM X 35 MM (TI-6AI-4V ELI)
• Type of Device: PEDICLE SCREW SPINAL 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: 7362721
• MDR Text Key: 103532191
• Report Number: 2027467-2018-00016
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K033090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 62065-35
• Device Catalogue Number: 62065-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• 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): Other
• Patient Age: 75 YR