Speed SE-1512Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810633020166), received between Apr 5, 2016 and Sep 28, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 27, 2022Open, Classified

   The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

   Z-0099-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SPEED COMPRESSION IMPLANT KIT IN QUESTION WAS FOUND TO CONTAIN A 13MM DRILL GUIDE. TO CONTINUE THE PROCEDURE, THE SALES REP OPENED ANOTHER IMPLANT, WHICH CONTAINED THE PROPER DRILL GUIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A DELAY OF APPROXIMATELY TWO MINUTES. NO FRAGMENTS WERE GENERATED AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A SPEED 15X12X12MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501063 ↗
• MalfunctionSep 23, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473011 ↗
• MalfunctionAug 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS DISCOVERED DURING AN UNKNOWN PROCEDURE THAT THE WRONG SIZE DRILL GUIDE WAS PACKAGED WITH THE SE-1512 IMPLANT KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SPEED 15X12X12MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198433 ↗
• MalfunctionSep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, SPEED COMPRESSION IMPLANT KIT DEPLOYED FROM INSERTER BEFORE PRODUCT WAS READY TO BE IMPLANTED. SURGICAL STAFF ATTEMPTED TO REATTACH THE IMPLANT TO THE INSERTER AND THE IMPLANT FELL OFF ON THE FLOOR. CONCOMITANT DEVICES REPORTED: UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SPEED 15X12X12MM IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440500 ↗
• MalfunctionFeb 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  FURTHER IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING OLECRANON FRACTURE PROCEDURE AND PATIENT'S OUTCOME IS REPORTED AS POSITIVE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9716576 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED (SE-1512) WAS INSERTED APPROPRIATELY DURING LAPIDUS PROCEDURE (B)(6) 2014. FOLLOW-UP X-RAY IN (B)(6) 2015 REVEALED THAT IMPLANT HAD BROKEN AFTER PATIENT REPORTED TRIPPING. PATIENT HAS NOT REQUIRED REVISION SURGERY, NOR REMOVAL OF BROKEN IMPLANT. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5548797 ↗