MAUDE Adverse Event Report: ALPHATEC SPINE INC XENON POLYAXIAL SCREW Ø6.2 MM, 40 MM (TI-6AI-4V ELI); PEDICLE SCREW SPINAL SYSTEM

Model Number 12VFP62-40

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records found no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released in accordance with the device master record.An evaluation of the returned implants found the set screw remained securely attached within the head of the polyaxial screw.The explanted rod contains marking which indicate the set screw was fully tightened with distributed loading on the rod.There is also evidence of rod motion/slipping throughout the length of the rod.Although the wear patterns on the returned product are indicative of a construct that was properly final tightened, root cause cannot be determined.

Event Description

The initial surgery was performed on (b)(6) 2018 from the l3-l5.After the surgery, the surgeon planned to conduct a revision surgery (for an unrelated issue) to replace some screws and extend the fixation range to s1.The revision surgery was performed on (b)(6) 2018.When the surgeon was about to remove the set screw with a set screwdriver, the poly-axial screw suddenly came off even though the set screw was not rotated.The rod as not able to be inserted between the poly-axial screw and the set screw.

• Brand Name: XENON POLYAXIAL SCREW Ø6.2 MM, 40 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: 7373362
• MDR Text Key: 103945100
• Report Number: 2027467-2018-00015
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

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: 12VFP62-40
• Device Catalogue Number: 12VFP62-40
• Device Lot Number: 7518606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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: 77 YR