IMPIX 3D Print B242C12062810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03613720270546), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K163595); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jul 12, 2023Class IIOpen, Classified

   There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

   Z-2452-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM A PATIENT'S HUSBAND REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD LEG NUMBNESS AND BACK PAIN. THE CAGE HAS MOVED SINCE SURGERY AND SCREWS LOOSENING WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. PATIENT'S SPOUSE REPORTED THAT HIS WIFE IS HAVING LEG NUMBNESS ON LEFT SIDE AND LEG WEAKNESS AND EXPERIENCING NERVE PAIN FROM LOWER BACK TO HER HIP DOWN HER LEG TO HER TOES. SHE CAN¿T STAND FOR A LONG PERIOD OF TIME DUE TO WEAKNESS. THE PATIENT HAD HER FIRST SURGERY ON (B)(6) 2021 AND ALSO HAD A 2ND SURGERY ON (B)(6) 2024 WHICH WAS A REVISION SURGERY. THE REASON FOR REVISION SURGERY IS UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration; Numbness; Pain

  MAUDE report 20366430 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163595. One submission often covers many models, so check the product and lot details in each record.

• Z-1156-2020 · Oct 2, 2019 · Terminated
  Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010