NA 03.622.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034718187), received between Jul 25, 2017 and Jan 3, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 A THORACIC PEDICLE PROBE BROKE INTRA-OPERATIVELY AND THE FRAGMENT REMAINED IN THE PATIENT'S SACRUM. THE SURGEON WOULD LIKE TO KNOW THE EXACT METAL COMPOSITE OF THE PROBE AND THE MRI COMPATIBILITY. THERE WAS A FIFTEEN (15) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A PATIENT OUTCOME REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) THORACIC PEDICLE PROBE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439929 ↗
• MalfunctionMar 25, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, WHILE CANNULATING S1 PEDICLE, THE MATRIX THORACIC PEDICLE PROBE BROKE CAUSING A DELAY. FRAGMENT WAS RETRIEVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIFTY-FIVE MINUTES OF SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) THORACIC PEDICLE PROBE. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570114 ↗
• InjuryFeb 23, 2018Break; Break

  IT WAS REPORTED THAT A PEDICLE PROBE TIP BROKE OFF INTO THE PATIENT AT THE S1 LEVEL ON THE PATIENT'S RIGHT SIDE DURING A L4-L5/S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2018. THE PROCEDURE WAS BEING PERFORMED TO TREAT THE PATIENT¿S DEGENERATIVE SPINE. THE FRAGMENT WAS DIFFICULT TO REMOVE AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS DELAYED 10-15 MINUTES. ADDITIONAL X-RAYS WERE TAKEN AND ARE AVAILABLE FOR REVIEW. THE PATIENT WAS REPORTED TO HAVE HARD BONE. THE SURGEON USED A SIMILAR PROBE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT WAS HAVING PAIN DUE TO THE RETAINED FRAGMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7293105 ↗
• MalfunctionJan 4, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGEON WAS DOING A POSTERIOR FUSION CASE ON (B)(6) 2017 ON A PATIENT WITH VERY HARD BONE. HE WAS CREATING A PATH WITH HIS THORACIC PEDICLE PROBE FOR THE SCREW AND WHILE DOING SO, THE PEDICLE PROBE BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVE, HOWEVER IS NOT AVAILABLE FOR RETURN. THE PROBE ITSELF WILL BE RETURNED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) THORACIC PEDICLE PROBE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7164474 ↗
• InjuryJul 25, 2017Break; Break

  IT WAS REPORTED THAT DURING AN L5-S1 LAMINECTOMY DECOMPRESSION FUSION WITH EXPEDIUM ON (B)(6) 2017, 30 MM OF THE DISTAL END OF THE THORACIC PEDICLE PROBE BROKE OFF IN THE LEFT L5 PEDICLE. THE SURGEON WAS CANNULATING THE PEDICLE TO CREATE A PATH TO INSERT THE BONE SCREWS. AS THE SURGEON WAS REMOVING THE THORACIC PEDICLE PROBE FROM THE PEDICLE, THE DISTAL END OF THE PROBE BROKE OFF. THE SURGEON USED A SCREW EXTRACTOR IN AN ATTEMPT TO REMOVE THE BROKEN TIP. THE SCREW EXTRACTOR WAS TOO BIG AND THE SURGEON WAS UNABLE TO RETRIEVE THE TIP. NO OTHER ATTEMPTS WERE MADE TO REMOVE THE TIP. UNANTICIPATED X-RAYS WERE TAKEN TO LOCATE THE BROKEN TIP. THERE WAS AN APPROXIMATE 2 HOUR SURGICAL DELAY IN THE ATTEMPT TO REMOVE THE BROKEN TIP. AS THE TIP WAS LEFT IN THE PEDICLE, THE SURGEON WAS UNABLE TO PLACE A BONE SCREW IN THE LEFT L5 PEDICLE. THE SURGEON HAD TO GO UP 2 LEVELS (L3-L4, L4-L5) ABOVE THE NORMAL INDICATED PROCEDURE. THE SURGEON TRIED GOING UP ONE LEVEL TO L4-L5. THE LEFT SIDE OF THE PEDICLE AT L4-L5 WAS TOO SMALL AND THE SURGEON WAS UNABLE TO CREATE A PATH FOR THE BONE SCREWS. THE SURGEON HAD TO GO UP ANOTHER LEVEL TO L3-L4 AND WAS ABLE TO INSERT THE BONE SCREWS INTO THE PEDICLE AT L3-L4

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Code Available

  MAUDE report 6740449 ↗