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Sypher ALIF Spacer System SAS-3212Recalls & reported problems

Biogennix, LLC · Sypher Locking Cover Plate - 32mm X 12mm. Prohibits Bone Screw backout after implantation. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812593020330), received between Dec 5, 2016 and Dec 5, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 18, 2026.

Most reported problems

Device problems

  • Failure to Align1
  • Patient-Device Incompatibility1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 5, 2016Failure to Align; Patient-Device Incompatibility

    DURING A PROCEDURE, ON (B)(6) 2016, THE DOCTOR ENCOUNTER AN OSTEOPHYTE NEAR THE IMPLANT SITE THAT IMPEDED DIRECT ALIGNMENT OF THE SYPHER LOCKING COVER PLATE ASSEMBLY TO THE IMPLANTED SYPHER SPACER. THE COVER PLATE SCREW AND THE SPACER INSERT WERE NOT PROPERLY ALIGNED USING THE FREE-HAND TECHNIQUE, RESULTING IN CROSS-THREADING OF THE SCREW INTO THE SPACER INSERT TO A DEGREE THAT PREVENTED THE SCREW FROM BEING FULLY SEATED AS WELL AS IMPOSSIBLE TO REMOVE THE SCREW BY UNSCREWING IT FROM THE COVER PLATE. THE DOCTOR THEN ATTEMPTED TO REMOVE THE LOCKING COVER PLATE SCREW USING PLIERS AND IN THE PROCESS THE SPACER INSERT WAS PULLED OUT OF THE SPACER ALONG WITH THE LOCKING COVER PLATE ASSEMBLY. SINCE THE SYPHER SPACER WAS FIRMLY FIXED IN PLACE WITH THE THREE SYPHER TITANIUM SCREWS, THE DOCTOR DECIDED TO FINISH THE PROCEDURE WITHOUT A LOCKING COVER PLATE ASSEMBLY. IN A FOLLOW-UP WITH THE DOCTOR ON (B)(6) 2016, HE INDICATED THAT THE PATIENT WAS DOING WELL AND THAT IN FUTURE SITUATIONS HE WOULD REMOVE ANY OBSTRUCTING OSTEOPHYTES PRIOR TO SYPHER SPACER IMPLANTATION. BIOGENNIX ASSESSMENT: BIOGENNIX RECEIVED THE RETURNED SYPHER LOCKING PLATE ASSEMBLY COMPONENTS RELATED TO THIS COMPLAINT. THE INV

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6146011 ↗

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Sources and updates

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