CONCORDE 287908008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034220147), received between Jan 2, 2020 and Mar 7, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553129 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553110 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THORACOLUMBAR POSTERIOR FUSION (L4/ L5) FOR ADULT SPINAL DEFORMITY ON (B)(6)2024. IN THE SURGERY, DURING USE OF THE BONE FUNNEL IN QUESTION, WHEN THE UPPER PART OF THE OUTER TUBE WAS STRUCK SEVERAL TIMES WITH A MEDICAL HAMMER (PLASTIC) WHILE THE INNER TUBE PART WAS REMOVED, AN UNUSUAL NOISE WAS HEARD AND THE WELDING PART BETWEEN THE BONE SUPPORT PART OF THE UPPER PART OF THE OUTER TUBE AND THE 8 MM OUTER TUBE PART DISINTEGRATED. THE USE WAS DISCONTINUED IMMEDIATELY AND BONE GRAFTING WAS PERFORMED BY ANOTHER METHOD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE CONCORDE SYSTEM BONE FUNNEL 8MM THIS IS REPORT 1 OF 1 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720245 ↗
• MalfunctionJul 6, 2023Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PLASTIC ON PUSHER WAS CRACKED. NO OTHER INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267594 ↗
• MalfunctionMar 1, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A SPINAL FUSION (L4/5) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON, WHEN THE SURGEON TAPPED THE FUNNEL WITH A PLASTIC HAMMER, IT CAUSED THE COMPONENT IN THE TRIANGULAR PYRAMID SHAPE TO BREAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT HAD NO ADVERSE EFFECT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636045 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT, THE CONCORDE BONE FUNNEL WAS BROKEN. THIS REPORT IS FOR ONE (1) CONCORDE SYSTEM BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452426 ↗
• MalfunctionSep 21, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN THE DISTRIBUTOR WAS PREPARING THE FUNNEL FOR AND UPCOMING PROCEDURE, IT BROKE WHERE THE FUNNEL AND THE PLUNGER ROD WERE CONNECTED. THIS REPORT INVOLVES ONE (1) CONCORDE SYSTEM BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559950 ↗
• MalfunctionJul 14, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. WHILE THE SURGEON WAS TAPPING THE BONE FUNNEL WITH AN UNKNOWN DEVICE, THE CONNECTING SECTION BETWEEN THE SILVER FUNNEL AND THE ROD BROKE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272457 ↗
• MalfunctionJan 2, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) PROCEDURE (L4-5) TREATING SPINAL STENOSIS ON (B)(6) 2019. WHILE THE SURGEON WAS HAMMERING THE BLACK PART OF THE BONE FUNNEL, THE SILVER FUNNEL CAME OFF. A REPLACEMENT WAS AVAILABLE FOR USE. IT WAS CONFIRMED THAT NO FRAGMENT LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICES: HAMMER/IMPACTION INSTRUMENT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538230 ↗