Speed Titan SE-1515TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00810633021514), received between Apr 5, 2016 and Sep 14, 2022 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE STAPLE WASN'T LOADED ONTO THE INSERTER PROPERLY AND WOULD NOT FIT INTO THE HOLES DRILLED THROUGH THE GUIDE. A DIFFERENT STAPLE WAS USED. THE SURGERY WAS COMPLETED WITH TWO TO FIVE MINUTES OF DELAY. THIS REPORT IS FOR A SPEEDTITAN COMPRESSION IMPLANT KIT 15X15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422003 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 PSI GROUP FAILED TO MAKE 3MM HOLES. THE EVENT DID NOT OCCUR DURING STERILE PROCESS NOR DURING FIELD INSPECTION. IT OCCURRED DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232481 ↗
• MalfunctionFeb 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SPEEDTITAN COMPRESSION IMPLANT KIT ON THE INSERTER WAS UNUSABLE, DIRECTLY OUT OF THE PACKAGING. THE PLASTIC INSERTER DEFORMED AND CONTINUOUS COMPRESSION IMPLANT (CCI) DEVICE WAS NOT ABLE TO FIT IN PREDRILLED HOLES DUE TO PARTIALLY COMPRESSED. ANOTHER PACKAGE ITEM HAS THE SAME DEFECT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13452742 ↗
• MalfunctionFeb 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 7, 2022, THE SPEEDTITAN COMPRESSION IMPLANT KIT ON THE INSERTER WAS UNUSABLE, DIRECTLY OUT OF THE PACKAGING. THE PLASTIC INSERTER DEFORMED AND CONTINUOUS COMPRESSION IMPLANT (CCI) DEVICE WAS NOT ABLE TO FIT IN PREDRILLED HOLES DUE TO PARTIALLY COMPRESSED. ANOTHER PACKAGE ITEM HAS THE SAME DEFECT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE.THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15.THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13452701 ↗
• MalfunctionFeb 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CIRCULATING NURSE OPENED A 15X15 SPEED, TITAN STAPLE, TO THE BACK TABLE. THE STAPLE WAS NOT CONNECTED TO THE INSERTER WHEN OPENED. THE DOCTOR AND PA TRIED TO RELOAD THE STAPLE BUT COULD NOT. A NEW 15X15 STAPLE WAS OPENED. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) SPEED TITAN 15X15X15MM IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417330 ↗
• MalfunctionJan 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY IT WAS DISCOVERED THAT SPEEDTITAN COMPRESSION IMPLANT KIT WAS IMPROPERLY LOADED IN THE INSERTION ON THE DEVICE. ALSO, IT WAS DAMAGED, AND THE LEGS OF THE STAPLE WERE NO LONGER 15MM WIDE THEY WERE SHORTER AND CCI DID NOT LINE UP WITH THE HOLES DRILLED. THERE WERE FOUR MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) LARGE HANDLE WITH QUICK COUPLING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196934 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT'S STAPLE IMPLANT FOR MIDFOOT FUSION IS BROKEN AND THE PATIENT WANTS A REVISION SURGERY. PATIENT HAD A FOOT INFECTION ONE YEAR EARLIER WHICH PROHIBITED THE SURGERY FROM HAPPENING THEN. THIS REPORT IS FOR A SPEEDTITAN(TM) IMPLANT KIT 15 X 15 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239036 ↗
• MalfunctionApr 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A FOOT SURGERY PROCEDURE USING THE BME SPEED TITAN STAPLE IN QUESTION. IT WAS OBSERVED THAT THE STAPLE HAD ALREADY DISENGAGED FROM THE INSERTION HANDLE IN THE PACKING BEFORE USE. ANOTHER STAPLE WAS OPENED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWO (2) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL INSERTION HANDLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657155 ↗
• InjuryJan 29, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING BASE WEDGE OSTEOTOMY SURGERY, WHEN DOING THE BASE SWITCH OSTEOTOMY AND THE SPEEDTITAN IMPLANT SHIFT THE OSTEOTOMY AND BROKE THE WEDGE. THE SURGEON CHANGED HIS PLAN AND MODIFIED THE SCREW FIXATION INSTEAD OF THE SPEEDTITAN IMPLANT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11253271 ↗
• MalfunctionOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BME STAPLE WAS NOT FULLY LOADED IN INSERT APPLICATOR. EVERYTHING IS STILL IN STERILE PACKAGE, AND A GRAPHIC CASE IS FLAKING AND INSTRUMENT NUMBERS WERE FADING. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10635348 ↗
• MalfunctionJul 30, 2019Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  T WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FIELD INVENTORY, A TWO (2) SPEED TITAN COMPRESSION IMPLANT STAPLES HAD BROKEN THROUGH THE PLASTIC INSERTER DEVICE IN THE STERILE PACKAGING. THE IMPLANT LOOKS LIKE THEY HAVE BEEN COMPROMISED AND ARE NOT ABLE TO USE FOR SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843802 ↗
• MalfunctionJul 30, 2019Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FIELD INVENTORY, A TWO (2) SPEEDTITAN COMPRESSION IMPLANT STAPLES HAD BROKEN THROUGH THE PLASTIC INSERTER DEVICE IN THE STERILE PACKAGING. THE IMPLANT LOOKS LIKE THEY HAVE BEEN COMPROMISED AND ARE NOT ABLE TO USE FOR SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843797 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO SPEED TITAN COMPRESSION IMPLANTS KIT WAS ALREADY DEPLOYED FROM THE ACTUAL DEPLOYING DEVICE. THIS WAS NOTICED FROM THE TRUNK STOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED TITAN IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378402 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO SPEED TITAN COMPRESSION IMPLANTS KIT WAS ALREADY DEPLOYED FROM THE ACTUAL DEPLOYING DEVICE. THIS WAS NOTICED FROM THE TRUNK STOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED TITAN IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378401 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) HAMMERLOCK 2 IMPLANT ANGLED LARGE BOX GOT DAMAGED THAT CAN CAUSE POSSIBLE CONTAMINATION OF THE IMPLANT. THE HAMMERLOCK 2 IMPLANT LARGE AND HAMMERLOCK 2 IMPLANT SMALL HAVE COME OFF THE INSERTER. THE SPEEDTITAN COMPRESSION IMPLANT BROKEN THROUGH THE UNKNOWN INSERTER. THE PACKAGES OF THE SPEEDARC COMPRESSION IMPLANT AND SPEEDTRAID IMPLANT SIZING GUIDE GOT DAMAGED AND CAN CAUSE POSSIBLE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN INSERTION INSTRUMENT: TRAUMA (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333401 ↗
• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT THE 2.65 MM DRILL GUIDE BROKE OFF AT THE NECK JUNCTION OF THE DRILL GUIDE DURING A PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. CONCOMITANT DEVICE(S) REPORTED: SPEED TITAN COMPRESSION IMPLANT (PART #: SE-1515TI, LOT #: BSE170019, QTY: 1). THIS COMPLAINT INVOLVES 1 PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201716 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED TITAN (SE-2020TI) WAS INSERTED APPROPRIATELY DURING TN FUSION PROCEDURE (B)(6) 2015. FOLLOW-UP X-RAY (B)(6) 2015 REVEALED THAT IMPLANT HAD BROKEN. 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 5549400 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED TITAN (SE-1515TI) WAS INSERTED APPROPRIATELY DURING LAPIDUS PROCEDURE (B)(6) 2015. FOLLOW-UP X-RAY MID (B)(6) 2015 REVEALED THAT IMPLANT HAD BROKEN. 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 5549329 ↗