Nucleus Z277598Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 09321502022385), received between Sep 4, 2017 and Jun 5, 2023 — classified as 36 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (P970051); they may or may not involve this specific model.

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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE SURGEON, THE PATIENT EXPERIENCED A WEIGHT LOSS RESULTING IN THE ABUTMENT BEING MORE OBVIOUS, SO A SHORTER ABUTMENT WAS PLACED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2023. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17066732 ↗
• InjuryJun 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE SURGEON, THE PATIENT EXPERIENCED A WEIGHT LOSS RESULTING IN THE ABUTMENT BEING MORE OBVIOUS, SO A SHORTER ABUTMENT WAS PLACED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2023. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17066731 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. THE DEVICE (BOTH IMPLANT AND ABUTMENT) WAS EXPLANTED ON (B)(6) 2022. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE IN THE SAME PROCEDURE.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 16099820 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. THE DEVICE (BOTH IMPLANT AND ABUTMENT) WAS EXPLANTED ON (B)(6) 2022. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE IN THE SAME PROCEDURE.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 16099819 ↗
• InjurySep 27, 2022Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO SUSTAINING A HEAD TRAUMA (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2022.

  Patient problems: Head Injury; Inadequate Osseointegration

  MAUDE report 15494887 ↗
• InjurySep 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED UNDER GENERAL ANAESTHESIA ON (B)(6) 2022, DUE TO PAIN AND RETENTION ISSUES.

  Patient problems: Pain

  MAUDE report 15407850 ↗
• InjurySep 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED UNDER GENERAL ANAESTHESIA ON (B)(6) 2022, DUE TO PAIN AND RETENTION ISSUES.

  Patient problems: Pain

  MAUDE report 15407849 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS TREATED WITH IV ANTIBIOTICS. A SKIN REVISION WAS PERFORMED UNDER A GENERAL ANAESTHETIC WHERE THE ABUTMENT WAS CHANGED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 11587007 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS TREATED WITH IV ANTIBIOTICS. A SKIN REVISION WAS PERFORMED UNDER A GENERAL ANAESTHETIC WHERE THE ABUTMENT WAS CHANGED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 11587002 ↗
• InjuryOct 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SUPPURATION (INFECTION) AND SKIN OVERGROWTH OF THE ABUTMENT. TREATMENT TO THE INFECTION IS UNKNOWN).

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 10702282 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION WHICH WAS SUCCESSFULLY TREATED WITH ORAL AND TOPICAL ANTIBIOTICS.

  Patient problems: Discharge; Patient Problem/Medical Problem; Skin Inflammation

  MAUDE report 10228787 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION WHICH WAS SUCCESSFULLY TREATED WITH ORAL AND TOPICAL ANTIBIOTICS.

  Patient problems: Discharge; Patient Problem/Medical Problem; Skin Inflammation

  MAUDE report 10228747 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Skin Inflammation; Swelling

  MAUDE report 9589617 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Skin Inflammation; Swelling

  MAUDE report 9589615 ↗
• InjuryJan 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE ABUTMENT WAS CHANGED UNDER A GENERAL ANAESTHETIC.

  Patient problems: No Code Available

  MAUDE report 9579572 ↗
• InjuryJan 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE ABUTMENT WAS CHANGED UNDER A GENERAL ANAESTHETIC.

  Patient problems: No Code Available

  MAUDE report 9579570 ↗
• InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH WHICH WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: No Code Available

  MAUDE report 9556290 ↗
• InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH WHICH WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: No Code Available

  MAUDE report 9556289 ↗
• InjuryDec 23, 2019Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE.

  Patient problems: No Code Available

  MAUDE report 9508959 ↗
• InjuryDec 22, 2019Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE.

  Patient problems: No Code Available

  MAUDE report 9508895 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE WHICH WAS TREATED WITH A ANTIBIOTIC (ORAL AND TOPICAL). THE DEVICE WAS EXPLANTED UNDER A GENERAL ANAESTHETIC (B)(6) 2019.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9493085 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE WHICH WAS TREATED WITH A ANTIBIOTIC (ORAL AND TOPICAL). THE DEVICE WAS EXPLANTED UNDER A GENERAL ANAESTHETIC (B)(6) 2019.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9493076 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE THAT WAS TREATED WITH ANTIBIOTICS (ORAL AND TOPICAL). THE IMPLANT REMAINS IN-SITU.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9492982 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE THAT WAS TREATED WITH ANTIBIOTICS (ORAL AND TOPICAL). THE IMPLANT REMAINS IN-SITU.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9492954 ↗
• InjuryDec 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF THE ABUTMENT SECONDARY TO AN INFECTION AT THE ABUTMENT SITE.

  Patient problems: Unspecified Infection

  MAUDE report 9414645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970051. One submission often covers many models, so check the product and lot details in each record.

• Z-2155-2015 · Jun 5, 2015 · Terminated
  Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, t
• Z-0003-2012 · Sep 16, 2011 · Terminated
  Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant
• Z-0119-2010 · Sep 30, 2009 · Terminated
  Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.