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

Model Number	PP40-28100
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3005819474-2023-00004
• Device Sequence Number: 5543599
• Product Code: MAX
• UDI-Device Identifier: 00840996118187
• UDI-Public: 00840996118187
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K162103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male