Encore System FG0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00862211000206), received between Jan 25, 2023 and May 8, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Insufficient Device Problem Information

  THE PHYSICIAN TREATED THE PATIENT WITH A HYOID SUSPENSION USING THE ENCORE SYSTEM. THE PATIENT LATER DEVELOPED AN INFECTION IN THE UPPER INCISION SITE OF THE BONE ANCHOR PLACEMENT. THE PATIENT WAS GIVEN A COURSE OF ANTIBIOTICS AND A LAYERED CLOSURE WAS MADE TO ISOLATE THE INFECTION.

  Patient problems: Skin Infection

  MAUDE report 25124925 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  THE PHYSICIAN TREATED THE PATIENT WITH A HYOID SUSPENSION USING THE ENCORE SYSTEM. THE PATIENT LATER DEVELOPED AN INFECTION IN THE UPPER INCISION SITE OF THE BONE ANCHOR PLACEMENT. THE PATIENT WAS GIVEN A COURSE OF ANTIBIOTICS AND A LAYERED CLOSURE WAS MADE TO ISOLATE THE INFECTION.

  Patient problems: Skin Infection

  MAUDE report 25124767 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN IMPLANT ON (B)(6) 2024. THE AREA BECAME INFECTED WITH STREP. INTERMEDIUS AND WAS TREATED WITH ANTIBIOTICS (PO AND IV). THE DEVICE WAS LATER EXPLANTED ON (B)(6) 2024.

  Patient problems: Pharyngitis

  MAUDE report 19983586 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE INITIAL PROCEDURE WAS NOT EFFECTIVE. A FOLLOW-UP EXAMINATION BY A SECOND PHYSICIAN NOTED THAT THE SUTURES WERE INSUFFICIENTLY TENSIONED. A THIRD PHYSICIAN PERFORMED A SLEEP STUDY AND AIRWAY EXAMINATION. A SECOND PROCEDURE, CONSISTING OF EITHER A TONGUE SUSPENSION OR TIGHTENING OF THE EXISTING SUTURES, DID NOT RESOLVE THE PATIENTS SNORING.

  Patient problems: Apnea

  MAUDE report 19164296 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED WITH THE ENCORE SYSTEM AND ABOUT 2 WEEKS LATER PRESENTED WITH NECK SWELLING AND AN INFECTION AT THE LOWER INCISION. THE INCISION WAS DRAINED AND PACKED TO TREAT THE INFECTION AND THE PATIENT WAS TREATED WITH AUGMENTIN. THE SYMPTOMS WORSENED, THE PHYSICIAN OPENED AND DRAINED THE INCISION AND CONTINUED THE PATIENT ON AUGMENTIN. ABOUT 1 MONTH LATER, THE DRAINAGE HAS IMPROVED. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE DUE TO PERSISTENT DRAINAGE. NOTHING OF NOTE WAS OBSERVED DURING THE EXPLANT OR EXPLORATION.

  Patient problems: Skin Infection

  MAUDE report 18697495 ↗
• InjuryFeb 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PHYSICIAN REPORTED THE PATIENT WAS TREATED WITH THE ENCORE SYSTEM ON 11/16/2023. THE INITIAL TREATMENT WENT WELL, HOWEVER THE INCISION WAS LATER NOTED TO BE "OOZING". A NEGATIVE CULTURE WAS REPORTED.

  Patient problems: Skin Infection

  MAUDE report 18678453 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN ENCORE SYSTEM. HE EXPERIENCED AN INFECTION, FOR WHICH HE RECEIVED ANTIBIOTIC THERAPY AND SURGICAL EXCESION OF GRANULATION TISSUE.

  Patient problems: Skin Infection

  MAUDE report 18625645 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE ENCORE SYSTEM ABOUT A YEAR AGO AND HAD EARLY DRAINAGE FROM THE SUPERIOR INCISION. THIS WAS TREATED WITH ANTIBIOTICS. RECENTLY A PIMPLE-LIKE STRUCTURE WS NOTED AT THE SUPERIOR INCISION. IT WAS NOT CULTURED AS AN INFECTION AND IS NOT PAINFUL. THE PATIENT WAS TREATED WITH ANTIBIOTICS, HOWEVER THIS DID NOT CLEAR THE AREA OF THE INCISION. THE PATIENT IS EXPECTED TO HAVE THE SYSTEM EXPLANTED IN THE NEXT 2-3 WEEKS TO ENSURE THE INCISION HEALS AND THE PATIENT CAN MOVE FORWARD WITH PACEMAKER IMPLANTATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18116224 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THE PATIENT WAS SUCCESSFULLY TREATED WITH THE ENCORE SYSTEM ON (B)(6) 2023. ON (B)(6) 2023, THE PHYSICIAN REPORTED AN UNHEALED WOUND, WITH A POST-OPERATIVE INFECTION. A COURSE OF ANTIBIOTICS CLEARED THE INFECTION, HOWEVER A REOCCURRENCE LEAD TO EXPLANT OF THE DEVICE. OF NOTE IS THAT THE PATIENT IS A HEALTHCARE WORKER AND A CULTURE CONFIRMED SERRATIA MARCESCENS, A COMMON ANTIBIOTIC RESISTENT BACTERIA RESPONSIBLE FOR HOSPITAL-ACQUIRED INFECTIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17214047 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN ENCORE SYSTEM AND APPROXIMATELY 2 1/2 MONTHS LATER DEVELOPED A SELF-LIMITING STITCH ABSCESS. THE PATIENT RECEIVED 2 DOSES OF STEROIDS AND ANTIBIOTICS. THE DEVICE WAS LATER EXPLANTED, THE WOUND HEALED AND THE PATIENT IS DOING WELL.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 16242214 ↗