activL® SW992KRecalls & reported problems
Aesculap AG · ACTIV L SUP.PLATE SIZE L 11°/SPIKES · Class 3 · Implant
All models of activL (16)
Data updated Oct 16, 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 04038653425907), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Biocompatibility1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2022Biocompatibility; Biocompatibility
IT WAS REPORTED TO AESCULAP INC., VIA THE ANNUAL ACTIVL ENHANCED SAFETY SURVEILLANCE STUDY (ESS) COVERING A REPORTING PERIOD FROM 01FEB2021 TO 31JAN2022, THAT AN UNKNOWN ACTIV L DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A POSTOPERATIVE "SENSORY NEUROLOGICAL SAFETY EVENT." THE INITIAL SURGERY OCCURRED ON AN UNSPECIFED DATE. THE PATIENT HAD BEEN TREATED AT THE L5-S1 LEVEL WITH THE SPIKE ENDPLATE. THE PATIENT DEVELOPED BILATERAL PARS FRACTURES 10 MONTHS AFTER HAVING THE ARTHROPLASTY DEVICE IMPLANTED. A PERMANENT IMPAIRMENT OCCURRED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE, ALTHOUGH IT HAD BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE XC 100031157 / 400562857. ASSOCIATED MEDWATCH REPORTS: 2916714-2022-00077 (400562857 - AE-QAS-SP42). 2916714-2022-00078 (400562858 - AE-QAS-SP42). 2916714-2022-00079 (400562859 - AE-QAS-SP42).
Patient problems: Pain
MAUDE report 15201551 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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