CastleLoc-P Anterior Cervical Plate System 6712-1741Recalls & reported problems
L&K Biomed CO. ,Ltd. · CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 41mm 1EA · Class 2 · Implant
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 08806189893509), received between Jun 26, 2017 and Jun 26, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (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
- Material Disintegration1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2017Material Disintegration; Material Disintegration
ON (B)(6) 2017, MED3 ASSOCIATES INC. (US DISTRIBUTOR OF AEGIS SPINE) REPORTED THE COMPLAINT TO AEGIS SPINE (US AGENCY OF L&K BIOMED), AND AEGIS SPINE REPORTED IT TO L&K BIOMED ON (B)(6) 2017. ACCORDING TO MED3 ASSOCIATES INC., DR. (B)(6) PERFORMED ACDF SURGERY ON (B)(6), 2016 USING CASTLELOC-P MODEL# IS 6712-1741 (2 LEVEL 41MM) AND LOT# IS UNKNOWN, AND UPON INVESTIGATION IT WAS DISCOVERED THAT THE CAM AT ONE OF THE C7 SCREWS HAD BROKEN OFF AT SOME POINT SINCE THE SURGERY IN (B)(6). THE PATIENT WAS ABOUT 7 WEEKS POST-OP AND DENIED FALLING OR ANY MOTOR VEHICLE ACCIDENT BUT HAS BEEN NON-COMPLIANT WITH HER NECK BRACE. DR.(B)(6) HAD RETRIEVED THE FREE-FLOATING CAM FROM THE PATIENT AND TOOK OUT THAT 16MM SCREW. HE DID NOT PUT IN A RESCUE SCREW BECAUSE THERE WAS NO LOCKING MECHANISM. MED3 ASSOCIATES INC. SAYS THAT THE PATIENT DOES NOT HAVE GREAT LORDOSIS AND IS RATHER STRAIGHT AND ALMOST KYPHOTIC ACCORDING TO PATIENT X-RAY PICTURE PROVIDED BY HOSPITAL, AND IT WAS SAID IT IS DIFFICULT TO ASSESS BUT I BELIEVE THERE MAY ALSO HAVE BEEN A NARROW DISK HEIGHT OF C7 - T1 ALONG WITH NOT WEARING HER NECK BRACE WHICH MAY HAVE CONTRIBUTED TO THE FORCES THAT WERE GENERATED TO CAUSE THE SCREW TO BACK O
Patient problems: Failure of Implant
MAUDE report 6668960 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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