GRYPHON PERMACORD 223146Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705024629), received between Dec 7, 2018 and Feb 8, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 18, 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.

• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DEASEY, M. J., ET AL (2020) SMALL, SHORT, OBLIQUE PATELLAR TUNNELS FOR PATELLAR FIXATION DO NOT INCREASE FRACTURE RISK OR COMPLICATIONS IN MPFL RECONSTRUCTION A RETROSPECTIVE COHORT STUDY. THE ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, VOL. 8, PAGES 1-7 (USA). THE STUDY EMPHASIZES ON THE EVALUATION OF THE RISK OF PATELLAR FRACTURE AND OTHER OUTCOMES ASSOCIATED WITH SMALLER (3.2-MM), SHORT, OBLIQUE PATELLAR TUNNELS AS COMPARED WITH SUTURE ANCHOR FIXATION IN MPFL RECONSTRUCTION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: A TOTAL OF 384 KNEES IN 352 PATIENTS UNDERGOING PRIMARY MPFL RECONSTRUCTION WERE IDENTIFIED. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: MPFL RECONSTRUCTION SURGERY. THE DEVICES INVOLVED WERE: GRYPHON ANCHOR. COMPLICATIONS DESCRIBED: OF THOSE PATIENTS TREATED WITH A GRYPHON ANCHOR, 3 REQUIRED REVISION SURGERY AND 9 HAD SUBSEQUENT JOINT INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11293929 ↗
• MalfunctionJan 23, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT TWO OF HIS GRYPHON P BR WITH PERMACORD PULLED OUT DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SALES REP STATED THAT THEY OPENED THREE BUT DID NOT USE THE THIRD DEVICE. THE CASE WAS COMPLETED WITH LUPINE. THERE WERE NO PATIENT CONSEQUENCES BUT A 30 MINUTE DELAY WAS REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271655 ↗
• MalfunctionJan 23, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT TWO OF HIS GRYPHON P BR WITH PERMACORD PULLED OUT DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SALES REP STATED THAT THEY OPENED THREE BUT DID NOT USE THE THIRD DEVICE. THE CASE WAS COMPLETED WITH LUPINE. THERE WERE NO PATIENT CONSEQUENCES BUT A 30 MINUTE DELAY WAS REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8271651 ↗
• InjuryDec 7, 2018Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth; Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE SALES REP'S GRYPHON BR ANCHORS WITH PERMACORD (LOT: L604137) WERE INSERTED INTO THE PATIENT, BUT AFTER THE SURGEON TIED THE KNOT IN THE SUTURE, THE SUTURE CAME LOOSE. THE SAME FAILURE OCCURRED FOR TWO OF THE SALES REP'S GRYPHON DS ANCHORS WITH PERMACORD (LOT: L918851). THE SALES REP STATED THAT THE CASE WAS COMPLETED BY DRILLING OVER THE ANCHORS TO IMPLANT COMPETITOR ANCHORS. THE SALES REP STATED ANOTHER BONE HOLE WAS CREATED AND A COMPETITOR'S ANCHOR WAS IMPLANTED. THERE WAS NO TIME DELAY TO THE CASE. THE ANCHORS ARE NOT BEING RETURNED, AS THEY ARE IMPLANTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8143622 ↗
• InjuryDec 7, 2018Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth; Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE SALES REP'S GRYPHON BR ANCHORS WITH PERMACORD (LOT: L604137) WERE INSERTED INTO THE PATIENT, BUT AFTER THE SURGEON TIED THE KNOT IN THE SUTURE, THE SUTURE CAME LOOSE. THE SAME FAILURE OCCURRED FOR TWO OF THE SALES REP'S GRYPHON DS ANCHORS WITH PERMACORD (LOT: L918851). THE SALES REP STATED THAT THE CASE WAS COMPLETED BY DRILLING OVER THE ANCHORS TO IMPLANT COMPETITOR ANCHORS. THE SALES REP STATED ANOTHER BONE HOLE WAS CREATED AND A COMPETITOR'S ANCHOR WAS IMPLANTED. THERE WAS NO TIME DELAY TO THE CASE. THE ANCHORS ARE NOT BEING RETURNED, AS THEY ARE IMPLANTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8143617 ↗