ALLY™ Bone Screw-L 12mm PD-32-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852776006317), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K121713); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 15, 2019Defective Component; Material Protrusion/Extrusion; Defective Component

  DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6 , ON A 59-YEAR-OLD FEMALE, A SURGEON REPORTED MAL-POSITION OF THE SUPERIOR ALLY BONE SCREW-L THROUGH CAVUX CERVICAL CAGE-L IMPLANT AT C4-C5 LEVEL UPON DELIVERY AND ADJUSTMENT WITH A SCREW DRIVER WITHOUT USE OF THE CAGE DELIVERY INSTRUMENT, RESULTING IN APPROXIMATELY 3MM OF EXCESS PROTRUSION FROM THE INTENDED SCREW PLACEMENT POSITION. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SCREW, RESULTING IN A SUCCESSFUL PLACEMENT. SURGEON EXPERIENCED SIMILAR ISSUE AT THE C5-C6 LEVEL, BUT THE PROTRUSION BEYOND THE CAGE WAS MINIMAL, AND SURGEON DID NOT ADJUST THE SCREW POSITION. SURGEON REPORTED THAT OVERALL THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE CLINICAL SEQUALAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121713. One submission often covers many models, so check the product and lot details in each record.

• Z-2428-2020 · Mar 29, 2019 · Terminated
  Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate f