activL® SW888KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963143817), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryJan 11, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW888K - ACTIV L INF.PLATE S1 SIZE XL 5°/SPIKES. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2021 AT L3/L4 AND L4/L5 DURING A LUMBAR TOTAL DISC REPLACEMENT (TDR). ACCORDING TO THE COMPLAINT DESCRIPTION, A RE-OPERATION/REMOVAL OF THE DEVICES DUE TO POST-OPERATIVE EVENTS, INCLUDING ANTERIOR AND LATERAL MIGRATION. A REVISION SURGERY WAS NECESSARY; A FUSION WAS PERFORMED. THE SURGICAL SITE DESCRIPTION WAS NOTED AS "NORMAL". ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00003 (400541665 - SW965), 9610612-2021-00814 (400541569 - SW891K).

  Patient problems: Failure of Implant

  MAUDE report 13231137 ↗