Skipjack 98-3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981138820), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, THE PATIENT UNDERWENT SPINAL SURGERY WITH THE SKIPJACK EXPANDABLE SYSTEM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DELIVERY TOWER UNLOCKED AFTER BEING MALLETED, DISENGAGED FROM THE IMPLANT AND TORE THE DURA UNDER AND AGAINST THE DISC SPACE. IT WAS NOTED BY THE REPORTER THAT THE PATIENT HAD A FAIRLY COLLAPSED DISC SPACE AND THE SURGEON HAD DONE QUITE A BIT OF MALLETING TO INSERT THE IMPLANT. THE DURA WAS REPAIRED INTRAOPERATIVELY, HOWEVER, IT WAS INDICATED BY THE REPORTER THAT IT WAS UNKNOWN IF THE PATIENT WOULD EXPERIENCE A FUTURE CSF LEAK. SURGERY WAS EXTENDED APPROXIMATELY 45 MINUTES AND A NEW INTERBODY WAS ABLE TO BE PLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ADDITIONAL INCIDENT. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Spinal Column Injury

  MAUDE report 9387685 ↗