SPIDER SCREW SCL-1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08057013140485), received between Aug 30, 2022 and Aug 24, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Material Fragmentation; Material Fragmentation

  THE COMPLAINT RECEIVED ON 8/2/2023 AND SUPPORTING DOCUMENTS (SPIDER SCREW PERFORMANCE QUESTIONNAIRE AND ADVERSE EVENT REVIEW EMPLOYEE / PATIENT QUESTIONNAIRE) STATE THAT AN 8MM SPIDER SCREW WAS REPLACED AFTER BECOMING MOBILE WITH THE 10MM SPIDER SCREW, WHICH IS THE SUBJECT OF THIS COMPLAINT. THE HEAD OF THE SPIDER SCREW BROKE OFF AT THE LAST SLIGHT ADJUSTMENT WHILE IT WAS BEING PLACED IN THE PATIENT'S MOUTH (ON PALATAL BETWEEN TEETH # 3 & 4). IT WAS REPORTED THAT NO DRILL WAS USED TO PLACE THE SCREW. THE HEAD OF THE SCREW WAS REMOVED FROM THE PATIENT'S MOUTH WITH NO INCIDENT AND NO PORTION OF THE DEVICE WAS SWALLOWED. AFTERWARDS, THE PERIODONTAL FLAP WAS OPENED TO ALLOW A GRIP ON THE BROKEN SCREW, AND THE REMAINDER OF THE SCREW WAS REMOVED FROM THE BONE. THE COMPLAINT FORM INDICATED THAT THE 36-YEAR-OLD PATIENT WAS NOT INJURED DURING THE DEVICE BREAKAGE. IN ADDITION, NO DOCTOR OR HOSPITAL VISIT WAS REQUIRED AND NO PRESCRIPTION MEDICATIONS WERE NEEDED. THE PATIENT REQUIRED A ROUTINE FOLLOW-UP VISIT FOR SURGICAL POST OP. THE DOCTOR'S OFFICE INDICATED THAT IF THE DEVICE MALFUNCTION WERE TO RECUR, IT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY BECAUSE THE PATIENT COUL

  Patient problems: Failure of Implant

  MAUDE report 17619473 ↗
• InjuryAug 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  WHEN THE DOCTOR TRIED TO SCREW A SPIDER SCREW INTO THE BONE OF A 15-YEAR OLD MALE PATIENT, THE SCREW BROKE IN HALF. IT WAS REPORTED THAT THE DOCTOR PREDRILLED BEFORE TRYING TO PLACE THE SCREW. THE COMPLAINT FORM INDICATED THAT THE PATIENT WAS NOT HARMED BUT MERELY INCONVENIENCED, AND THE PATIENT QUESTIONNAIRE SENT IN SUBSEQUENTLY BY THE DOCTOR ALSO INDICATED THERE WAS NO PATIENT INJURY BUT A PRODUCT/PERFORMANCE ISSUE. THE BROKEN DEVICE WAS RETRIEVED FROM THE PATIENT'S MOUTH AND THE PATIENT DID NOT SWALLOW ANY PORTION OF THE DEVICE. NO HOSPITAL VISIT WAS REQUIRED. THE DOCTOR MENTIONED ON THE PATIENT QUESTIONNAIRE THAT IF THE DEVICE MALFUNCTION WERE TO RECUR, IT WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. DESPITE THE FACT THAT THE DOCTOR REPORTED NO PATIENT INJURY, OT DECIDED TO REPORT THIS BECAUSE THE DOCTOR DID PRESCRIBE IBUPROFEN, AND A BONE GRAFT WAS PLACED AFTER THE BROKEN SCREW WAS REMOVED. A FOLLOW-UP APPOINTMENT WAS ALSO REQUIRED TO CHECK WHETHER THE BONE GRAFT WAS HEALED AND A NEW SPIDER SCREW COULD BE INSERTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15323032 ↗