Saffron 520340Recalls & reported problems
Coloplast A/S · Fixation Tool · Class 2 · Implant
Quick summary
The Coloplast Saffron fixation tool is used to attach surgical grafts inside the pelvis. Most of its 28 adverse event reports describe the anchor coming loose, pulling out or shifting out of place during surgery, along with an anchor tip that bent or would not release and shots firing into surrounding tissue. No deaths and no injuries are reported.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05708932757423), received between Nov 1, 2023 and Aug 12, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (26 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated26
- Break1
- Device Difficult to Setup or Prepare1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Device Difficult to Setup or Prepare; Device Dislodged or Dislocated; Device Difficult to Setup or Prepare; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS PERFORMING AN ANTERIOR REPAIR WITH AXIS DERMIS GRAFT, ATTACHING IT TO THE SACROSPINOUS LIGAMENT WITH THE SAFFRON FIXATION TOOL USING 2-0 POLYPROPYLENE SUTURE. THE SURGEON IMPLANTED BOTH SUTURES IN THE SACROSPINOUS LIGAMENT; HOWEVER, BOTH THE SURGEON AND THE SCRUB TECH STRUGGLED TO HEAR THE REQUISITE CLICK OF THE ANCHOR BEING SEEDED INTO THE TOOL. THE PHYSICIAN DID NOT FEEL LIKE THE DEVICE WAS WORKING PROPERLY BUT HE PROCEEDED. HE TUGGED ON BOTH SUTURES, AND THEY APPEARED TO BE LODGED WITHIN THE LIGAMENT. WHEN HE WAS TYING THE SUTURES DOWN, THE ANCHOR ON THE PATIENT¿S RIGHT-SIDE LIGAMENT DISLODGED. THE PHYSICIAN REQUESTED ANOTHER SAFFRON TOOL BECAUSE HE DID NOT BELIEVE THE FIRST ONE WAS WORKING PROPERLY. THE CIRCULATOR OPENED A SECOND SAFFRON TOOL, WHICH WAS FROM THE SAME LOT. AGAIN, BOTH THE SCRUB TECH AND THE PHYSICIAN STRUGGLED TO HEAR THE CLICK. HE WAS ABLE TO GET THE ANCHOR IMPLANTED INTO THE SACROSPINOUS LIGAMENT WITH SUCCESS. THERE WAS NO EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786959 ↗MalfunctionMar 12, 2024Material Twisted/Bent; Material Twisted/Bent
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON DEPLOYED THE DEVICE AND NOTED THAT IT WAS DIFFICULT TO REMOVE AFTER PLACING THE ANCHOR. AFTER EXAMINING THE DEVICE, IT WAS CONCLUDED THAT THE ANCHOR DEPLOYER WAS BENT AND UNABLE TO WITHDRAW BACK INTO HANDSET. SHE OPENED ANOTHER DEVICE AND COMPLETED CASE. IT WAS NOTED THERE WAS NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888095 ↗MalfunctionDec 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON COMPLAINED ABOUT HANDS BEING TOO SMALL TO REACH SSL AND MISFIRED MULTIPLE TIMES INTO SURROUNDING TISSUE. THERE WAS TISSUE IN THE ANCHORS THAT PULLED OUT. TOOL EVENTUALLY STOPPED FIRING AT THE SAME FORCE AND UNABLE TO PENETRATE SSL. IT WAS NOTED THERE WAS AN ANCHOR RETAINED IN THE TOOL. ANOTHER SAFFRON WAS OPENED, AND ANCHOR WAS PLACED SUCCESSFULLY INTO SSL ON FIRST TRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18336655 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326116 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325992 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325651 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325526 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325466 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325175 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325063 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324986 ↗MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324781 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18322325 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18322013 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321823 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321704 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321508 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321431 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321027 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320968 ↗MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320550 ↗MalfunctionDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18277185 ↗MalfunctionDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18276124 ↗MalfunctionDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE TIE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18275750 ↗MalfunctionDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR PULLED OUT DURING SUTURE PLACEMENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18275637 ↗
Other Fixation, non-absorbable or absorbable, for pelvic use devices
- Saffron 520350Coloplast A/S · Fixation, non-absorbable or absorbable, for pelvic use14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.