Reef TH TA2-005002Recalls & reported problems
Seaspine Orthopedics Corporation · TA Removal Tool · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981318406), received between Mar 26, 2025 and Sep 10, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Separation Failure1
Patient problems
- Dural Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722602 ↗InjuryMar 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2025, THE SURGEON WAS ATTEMPTING TO INSERT A TRIAL INTO THE PATIENT USING THE REEF TA INSERTER AND UPON MALLETING THE TRIAL INTO THE DISC SPACE, IT UNEXPECTEDLY DISLODGED AND MOVED INTO THE DURA. THE SURGEON WAS ABLE TO RETRIEVE THE TRIAL USING CURETTES AND OTHER INSTRUMENTS, BUT THE TA REMOVAL TOOL WAS NOT EFFECTIVE AS IT COULD NOT SECURELY GRIP THE BACK OF THE TRIAL. AFTER THE DURAL TEAR, THE SURGEON ATTEMPTED TO LOAD ANOTHER TRIAL, HOWEVER, THE SURGEON WAS ABLE TO DETACH IT BY HAND, INDICATING A POTENTIAL ISSUE WITH THE LOCKING MECHANISM. THIS ISSUE CAUSED A ONE HOUR DELAY WHILE THE SURGEON HAD TO REPAIR THE DURA. CUSTOMER CONFIRMS THE SURGEON FOLLOWED THE APPROPRIATE SURGICAL TECHNIQUE FOR LOCKING THE TRIAL ON THE INSERTER AND THAT THE PATIENT IS DOING WELL AFTER THE SURGERY.
Patient problems: Dural Tear
MAUDE report 21702148 ↗
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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