HARPOON™ Lumbar Spacer System PP40-25100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840996117944), received between Feb 17, 2023 and Feb 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  WE HAD A FEMALE 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. DR. (B)(6) CAN GIVE YOU X-RAYS AS NEEDED.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 16395669 ↗
• MalfunctionFeb 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  WE HAD A FEMALE 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 THE CAGES HAD BACKED OUT. DURING THE ORIGINAL SURGERY, EACH CAGE WAS VERIFIED TO BE IN OPTIMAL POSITION BY X-RAY. (B)(6) CAN GIVE YOU X-RAYS AS NEEDED.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 16395668 ↗