Erisma®-LP 18176550Recalls & reported problems
Clariance · POLYAXIAL REDUCTION SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700780618323), received between Dec 11, 2018 and Dec 11, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K153326); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Off-Label Use2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2018Off-Label Use; Off-Label Use
TWO WEEKS POST-OP ON A T10-L3 FUSION CONSTRUCT FOR VERTEBRAL FRACTURE TREATMENT, THE PEDICLE SCREW ON CONTRA-LATERAL SIDE WAS PULLED OUT OF PEDICLE. AS A CONSEQUENCE, THE SET SCREW LOOSENED. THE PATIENT NEEDED A REVISION SURGERY TO RESECURE THE CONSTRUCT. THE CONSTRUCT WAS LENGTHENED TO L4 AND PEDICLE SCREWS WHICH PULLED OUT WERE REPLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.
Patient problems: Failure of Implant
MAUDE report 8149919 ↗InjuryDec 11, 2018Off-Label Use; Off-Label Use
TWO WEEKS POST-OP ON A T10-L3 FUSION CONSTRUCT FOR VERTEBRAL FRACTURE TREATMENT, THE PEDICLE SCREW ON CONTRA-LATERAL SIDE WAS PULLED OUT OF PEDICLE. AS A CONSEQUENCE, THE SET SCREW LOOSENED. THE PATIENT NEEDED A REVISION SURGERY TO RESECURE THE CONSTRUCT. THE CONSTRUCT WAS LENGTHENED TO L4 AND PEDICLE SCREWS WHICH PULLED OUT WERE REPLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.
Patient problems: Failure of Implant
MAUDE report 8149918 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K153326. One submission often covers many models, so check the product and lot details in each record.
- Z-1986-2019 · Jul 1, 2019 · TerminatedErisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Eri
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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 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.
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