activL® SW970KRecalls & reported problems
Aesculap AG · ACTIV L INF.PLATE SIZE S 0°/SPIKES · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653425648), received between Jan 7, 2021 and Jan 7, 2021 — 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
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2021Migration; Migration
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ACTIV L IMPLANT. THE ACTIVL IMPLANT MIGRATED 4 MONTHS AFTER SURGERY. ORIGINAL SURGERY WAS ON 8/17/20; THE PROCEDURE WAS A TOTAL DISC REPLACEMENT (TDR). SOMETIME LATER, THE PATIENT WAS ON VACATION AND DID "SOMETHING IN OCEAN". . A REVISION SURGERY WAS NECESSARY. IMPLANT WAS REMOVED AND TREATMENT WAS FUSION ON (B)(6) 2020 ADDITIONAL INFORMATION WAS NOT PROVIDED. THE OPERATIVE REPORT WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER XC REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 2916714-2021-00001, 2916714-2021-00002.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11131103 ↗
Other PROSTHESIS, INTERVERTEBRAL DISC devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page