Pyramesh® Implant System 905-137Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00673978080659), received between Dec 20, 2019 and Jan 21, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH SPINAL DEGENERATION SUGGESTED FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT WHEN THE TITANIUM MESH WAS CUT IN VITRO, THE TITANIUM MESH FRACTURED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED. DEVICE IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206612 ↗
• MalfunctionJan 11, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT WITH DIAGNOSIS OF SPINAL DEGENERATION DISEASE. IT WAS REPORTED THAT THE MESH WAS BROKEN WHEN IT WAS CUT AND SO, DIDN'T IMPLANTED IN PATIENT. IT WAS MENTIONED THAT THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PROCEDURE OR SURGERY PERFORMED DURING THIS EVENT WAS MENTIONED AS "SPINAL DEGENERATION SURGERY" THERE WERE NO SYMPTOMS TO PATIENT REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146292 ↗
• MalfunctionNov 2, 2020Fracture; Fracture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A WITH AN INDICATION OF SPINAL DEGENERATION IN NEED OF SPINAL DEGENERATION SURGERY USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS FRACTURED DURING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10768811 ↗
• MalfunctionDec 20, 2019Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED AS PER A LITIGATION COMPLAINT THAT ON AN UNKNOWN DATE IN 2013, THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL INJURY CAUSED FROM AN ACCIDENT IN THE SCHOOL. ALLEGEDLY, A CERVICAL VERTEBRA WAS SURGICALLY IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE IMPLANT WAS FOUND BROKEN AND LOOSENED. NO MORE INFORMATION IS AVAILABLE NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9500883 ↗