GRYPHON DYNACORD 210123Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705029907), received between Mar 31, 2022 and Mar 27, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE GRYPHON P PK ANC-DYNA STR/BL DEVICE X3 AND 6.5 HEALIX ADVANCE KNOTLESSS PEEK X1 DEVICE BOXES WERE DAMAGED AND EXTERIOR BOXES WERE SLIGHTLY DAMAGED. IT WAS REPORTED THAT THE REPORTER WAS UNSURE IF THE BOXES WERE DAMAGED DURING SHIPMENT OR WHEN PLACED IN BOXES TO SHIP. IT WAS FURTHER REPORTED THAT THE SALES REP WAS UNSURE IF THE IMPLANTS WERE STILL STERILE OR NOT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710091 ↗
• MalfunctionMar 27, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE GRYPHON P PK ANC-DYNA STR/BL DEVICE X3 AND 6.5 HEALIX ADVANCE KNOTLESSS PEEK X1 DEVICE BOXES WERE DAMAGED AND EXTERIOR BOXES WERE SLIGHTLY DAMAGED. IT WAS REPORTED THAT THE REPORTER WAS UNSURE IF THE BOXES WERE DAMAGED DURING SHIPMENT OR WHEN PLACED IN BOXES TO SHIP. IT WAS FURTHER REPORTED THAT THE SALES REP WAS UNSURE IF THE IMPLANTS WERE STILL STERILE OR NOT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710060 ↗
• MalfunctionMar 27, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE GRYPHON P PK ANC-DYNA STR/BL DEVICE X3 AND 6.5 HEALIX ADVANCE KNOTLESSS PEEK X1 DEVICE BOXES WERE DAMAGED AND EXTERIOR BOXES WERE SLIGHTLY DAMAGED. IT WAS REPORTED THAT THE REPORTER WAS UNSURE IF THE BOXES WERE DAMAGED DURING SHIPMENT OR WHEN PLACED IN BOXES TO SHIP. IT WAS FURTHER REPORTED THAT THE SALES REP WAS UNSURE IF THE IMPLANTS WERE STILL STERILE OR NOT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710004 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF GRYPHON P PK ANC-DYNA STR/BL DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 539 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED SUPERIOR CAPSULAR RECONSTRUCTION OF THE SUPRASPINATUS CAPSULE WITH TENSOR FASCIA LATA AUTOGRAFT DUE TO SUPRASPINATUS TEAR. ACCORDING TO THE REPORT, THE PATIENT HAD LOOSENING OF THE GRAFT 279 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13970720 ↗