NA 698335325Recalls & reported problems
Depuy Spine, LLC · MODIFIED INSTRUMENT BENDER TIP, A 5 DEGREES · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034371061), received between Nov 2, 2022 and Jun 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED DURING SURGERY ON (B)(6) 2024, THE TIP OF INSTRUMENT BROKE DURING SURGERY. IT IS A "ROD BENDER" TIP AND IT BROKE DURING THE ROD BENDING PROCESS. NO INCIDENT OR FRAGMENTS REPORTED. NO SURGICAL DELAY. THE TIP OF A SIMILAR INSTRUMENT IS ALSO BENT OUT OF SHAPE FOLLOWING REPEATED USE OVER THE YEARS. ANOTHER "TIP" WAS USED. THE BROKEN/DAMAGED ONES ARE 5 DEGREE TIPS, SO SURGERY WAS COMPLETED USING 10 DEGREE TIPS. PROCEDURE WAS COMPLETED SUCCESSFULLY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19637689 ↗MalfunctionNov 2, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON WAS CORRECTING SCOLIOSIS WITH THE CUSTOM CORONAL BENDERS FROM THE EXPEDIUM 5.5 SYSTEM, AND ONE OF THE PIECES BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PATIENT WAS NOT IMPACTED. THE SURGERY WAS COMPLETED IN A TIMELY MANNER AND NO DELAYS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MODIFIED INSTRUMENT BENDER TIP, A 5 DEGREES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714499 ↗
Other BENDER devices
- MONARCH 277030000Depuy Spine, LLC · BENDER15 reports
- EXPEDIUM 299704190Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704195Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704200Medos International Sàrl · BENDER9 reports
- ALTALYNE 5161-04-1700Medos International Sàrl · BENDER8 reports
- EXPEDIUM 299704185Medos International Sàrl · BENDER8 reports
- NA 03.161.057Synthes GmbH · BENDER5 reports
- NA 03.221.251Synthes GmbH · BENDER4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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