Speed SE-1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633022023), received between May 15, 2019 and Nov 14, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A PATIENT IS SCHEDULED TO UNDERGO HARDWARE REMOVAL SURGERY ON (B)(6) 2019 DUE TO SUBOPTIMAL REPOSITION OF LUNATUM AND CAPITATUM. THE INITIAL PROCEDURE, FUSION OF CAPITATUM AND LUNATUM WITH TWO BME SPEED STABLES 13X10 AND 15X10 RESPECTIVELY OCCURRED ON AN UNKNOWN DATE. DURING FOLLOW UP AFTER 6 WEEKS, SUBOPTIMAL RESULT WAS OBSERVED, ALTHOUGH THE HAND WAS FIXED IN PLASTER CAST. THE STAPLES WILL BE REPLACED WITH TWO CANNULATED SCREWS IN THE PLANNED REVISION SURGERY. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 9). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 15X10X10MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9325243 ↗
• MalfunctionMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) SPEED COMPRESSION IMPLANT KITS WERE SHIPPED IN FOR A CASE, BUT THE STAPLES WERE NOTICED DISCONNECTED FROM THE INSERTER UPON ARRIVAL AND PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: INSERTER (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SPEED COMPRESSION IMPLANT KITS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8612977 ↗
• MalfunctionMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) SPEED COMPRESSION IMPLANT KITS WERE SHIPPED IN FOR A CASE, BUT THE STAPLES WERE NOTICED DISCONNECTED FROM THE INSERTER UPON ARRIVAL AND PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: INSERTER (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SPEED COMPRESSION IMPLANT KITS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8612957 ↗