MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE LUMBAR SPACER SYSTEM (HARPOON); HARPOON PLI SPACER 28X10,0 DEG

Model Number PP40-28100

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 12/27/2022

Event Type  malfunction  

Event Description

We had a male patient who had complained of either back pain, leg pain or weakness and had to be taken to the or to remove harpoon cage that have migrated out of the disc space.We did not place a new cage in any of the empty disc space where the cages had backed out.During the original surgery, each cage was verified to be in optimal position by x-ray.

Manufacturer Narrative

The cause of the expulsion is inconclusive however one factor leading to device expulsion appears to be patient non-compliance during recovery.Appropriate physical exertion following surgery is patient dependent and it is acknowledged that there is limited control in this area.The implant is designed to engage the endplates and provide resistance to migration when appropriately placed and sized.Therefore, another possible contributing factor to device expulsion could be that the implant was under sized to the shape and size of the disc space.

• Brand Name: CHOICESPINE LUMBAR SPACER SYSTEM (HARPOON)
• Type of Device: HARPOON PLI SPACER 28X10,0 DEG
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 16395692
• MDR Text Key: 309821598
• Report Number: 3005819474-2023-00004
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00840996118187
• UDI-Public: 00840996118187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PP40-28100
• Device Lot Number: 8162-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male