ENDOSKELETON® TT 4200-1021Recalls & reported problems
Medtronic Sofamor Danek, Inc. · Thin Implant Pusher · Class 1
Data updated Oct 18, 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 00191375003014), received between Apr 12, 2017 and Feb 22, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
- Device Dislodged or Dislocated1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2018Break; Break
PER THE SALES REPRESENTATIVE, ON (B)(6) 2017 THE SURGEON WAS USING THE THIN PUSHER TO POSITION THE IMPLANT DURING A TLIF AND THE THIN PUSHER BROKE. PER THE SALES REPRESENTATIVE, THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE AND COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7290586 ↗MalfunctionApr 12, 2017Break; Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A L4-L5 TLIF PROCEDURE, THE SURGEON WAS TAPPING THE THIN PUSHER WITH A MALLET WHEN THE TIP BROKE. THE TIP WAS EASILY AND PROMPTLY REMOVED. THE CASE CONTINUED AND COMPLETED WITH NO DELAY, ADVERSE EFFECTS OR INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6487253 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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