BEST PAK Access Needle PK1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853508002218), received between Jun 16, 2020 and Jun 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionJun 16, 2020Break; Material Fragmentation; Material Twisted/Bent; Break; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, INTRA-OP, THE BONE WAS HARD AND IT WAS MANAGED TO INSERT THE PRODUCT INTO THE PEDICLE, BUT THE INNER CYLINDER COULD NOT BE REMOVED AND IT WAS UNABLE TO PROCEED TO THE NEXT STEP. THEREFORE THE PROCEDURE WAS CHANGED TO OPEN. WHEN CHECKING THE IMAGE TO CHECK THE LEVEL IT WAS FOUND THAT FRAGMENTS OF THE OUTER CYLINDER HAVE REMAINED INSIDE THE PEDICLE AND INSIDE THE VERTEBRAL BODY. AN ATTEMPT WAS MADE TO REMOVE THE FRAGMENTS USING AIRTOME AND A PLIER BUT FAILED AND WOUND CLOSURE WAS PERFORMED WITH THE FRAGMENTS REMAINED BASED ON THE SURGEON'S JUDGEMENT THAT THE FRAGMENTS WOULD NOT COME OUT. THERE WAS A DELAY OF MORE THAN 60 MINUTES AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AN UPDATE WAS RECEIVED ON 31 MAR 2020: PROCEDURE INVOLVED: FIXATION AT TH10-L3 USING VOYAGER 55/60. THE BONE WAS HARD AND WHEN THE PAK WAS HAMMERED INTO THE LEFT SIDE OF THE L2 VERTEBRAL BODY, BUT THE INNER CYLINDER COULD NOT BE REMOVED. BY CHECKING THE IMAGE, THE NEEDLE APPEARED TO BE BENT, SO THE PAK NEEDLE ITSELF WAS PULLED OUT. IT WAS SAIS AT THIS POINT, IT WAS NOTICED THAT THE OUTER CYLINDER WAS BROKEN, BUT WHEN THE IMAGE WAS CHEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10157243 ↗