Malibu 91-6117Recalls & reported problems
Seaspine Orthopedics Corporation · Thoracic Probe, Curved Square Tip · Class 1
All models of Malibu (17)
Data updated Oct 16, 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 10889981082314), received between Dec 11, 2019 and Dec 11, 2019 — classified as 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
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IN AN L5-S1 PLIF, THE DISTAL TIP OF THE 91-6116 (THORACIC PROBE, SQUARE TIP) BROKE OFF INTO THE S1 PEDICLE. DR. (B)(6) WAS MALLETING THE PROBE INTO THE PEDICLE WHEN IT BECAME STUCK. THE SURGEON WAS UNABLE TO REMOVE THE PROBE. UPON FORCEFULLY TWISTING THE INSTRUMENT TO RETRIEVE IT FROM THE PEDICLE, THE PROBE BROKE, LEAVING THE TIP IMPLANTED IN THE PEDICLE. THE SURGEON ELECTED TO LEAVE THE TIP IMPLANTED IN THE PATIENT, WHILE TAKING INTO CONSIDERATION THAT HE WOULD HAVE HAD TO DAMAGE THE PATIENT'S BONE AND/OR ANATOMY IN ORDER TO RECOVER THE TIP. DR. (B)(6) STATED THE PATIENT HAD UNUSUALLY HARD BONE AND THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PLANS TO REVISE. THE PATIENT IS HEALING AS EXPECTED, WITH NO COMPLICATIONS DUE TO THE PRODUCT MALFUNCTION AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9451401 ↗MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IN AN L5-S1 PLIF, THE DISTAL TIP OF THE 91-6117 (THORACIC PROBE, CURVED SQUARE TIP) BROKE OFF INTO THE S1 PEDICLE. DR. (B)(6) WAS MALLETING THE PROBE INTO THE PEDICLE WHEN IT BECAME STUCK. THE SURGEON WAS UNABLE TO REMOVE THE PROBE. UPON FORCEFULLY TWISTING THE INSTRUMENT TO RETRIEVE IT FROM THE PEDICLE, THE PROBE BROKE, LEAVING THE TIP IMPLANTED IN THE PEDICLE. THE SURGEON ELECTED TO LEAVE THE TIP IMPLANTED IN THE PATIENT, WHILE TAKING INTO CONSIDERATION THAT HE WOULD HAVE HAD TO DAMAGE THE PATIENT'S BONE AND/OR ANATOMY IN ORDER TO RECOVER THE TIP. DR. (B)(6) STATED THE PATIENT HAD UNUSUALLY HARD BONE AND THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PLANS TO REVISE. THE PATIENT IS HEALING AS EXPECTED, WITH NO COMPLICATIONS DUE TO THE PRODUCT MALFUNCTION AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9451009 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- Sklar Instruments 94-5923Sklar Corporation · PROBE1 recall0 reports
- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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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