activL® SW981KRecalls & reported problems
Aesculap AG · ACTIV L SUP.PLATE SIZE M 6°/SPIKES · Class 3 · Implant
All models of activL (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653425822), received between Jul 7, 2020 and Aug 7, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration2
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant2
- Pain2
- Insufficient Information1
- Joint Disorder1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2020Migration
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ACTIV L PE-INLAY 8.5MM (REFERENCE MDR ID 2916714-2020-00284), AN ACTIV L SUP PLATE SIZE M 6°/SPIKES, AND AN ACTIV L INF PLATE S1 SIZE M 5°/SPIKES (REFERENCE MDR ID 2916714-2020-00282), FOR AN ACTIVE L PROSTHETIC DISC IMPLANT. ACCORDING TO THE COMPLAINT DESCRIPTION THE IMPLANT MIGRATED 8 WEEKS POSTOPERATIVE. THE IMPLANT MIGRATED ANTERIORLY. NO ISSUES ON TWO WEEK POSTOPERATIVE X-RAY IMAGES AND NO ISSUES IN THE SURGERY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 10380868 ↗InjuryJul 13, 2020Migration
NO UPDATES. ASSOCIATED MEDWATCH-REPORTS: 2916714-2020-00235, 2916714-2020-00244, 2916714-2020-00245.
Patient problems: Failure of Implant; Pain
MAUDE report 10266521 ↗InjuryJul 7, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem
ADDITIONAL DATA: LEVEL L5/S1. GENDER: MALE. IMPLANTATION DATE: (B)(6) 2019. (IMPLANTATION TIME 0.5 YEARS). EXPLANTATION DATE: (B)(6) 2020. REASON FOR REMOVAL: SEVERE BACK PAIN AND RIGHT LEG PAIN. ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00286 ((B)(4)/ SW965), AND 9610612-2020-00288 ((B)(4)/ SW986K).
Patient problems: Insufficient Information; Joint Disorder; Pain
MAUDE report 10240975 ↗
Other PROSTHESIS, INTERVERTEBRAL DISC devices
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- 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 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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