BioWick® SureLock® CM-6127Recalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868269769), received between Apr 16, 2020 and Aug 5, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Fluid Discharge1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2022Fracture; Fracture
IT WAS REPORTED DURING SURGERY WHEN IMPLANTING AN ANCHOR, THERE WAS DIFFICULTY IMPLANTING THE ANCHOR. ADDITIONALLY, THE UPPER PART OF THIS COMPLAINT PRODUCT'S ANCHOR CAME OFF, SO THE SURGEON REMOVED THE ANCHOR OF THIS PRODUCT FROM THE PATIENT'S BODY. THE REMAINING PART OF THE DEVICE WAS SUCCESSFULLY IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15175312 ↗InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER PROCEDURE APPROXIMATELY 6 MONTHS AGO. SUBSEQUENTLY, PATIENT'S WOUND BECAME INFLAMED, OOZING AND ANGRY AND PATIENT WAS REVISED ON AN UNKNOWN DATE. THERE WAS A CRATER IN THE BONE, POOR BONE QUALITY. POSSIBLE PATIENT REACTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fluid Discharge; Inflammation
MAUDE report 12249365 ↗InjuryApr 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PATIENT PRESENTED WITH BACK PAIN POST OPERATION AS PART OF A CASE STUDY. SURGEON ATTRIBUTED THE CAUSE OF THIS EVENT TO PRE-EXISTING CONDITIONS AND NOT RELATED TO THE DEVICE.
Patient problems: Pain
MAUDE report 9970089 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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