MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN OTOLOGIC REPAIR GRAFT

Model Number	G44839
Health Effect - Clinical Codes	Hearing Loss (1882); Perforation (2001); Therapeutic Effects, Unexpected (2099)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional mfg narrative-notes date of event not provided by the complainant, 510(k) k161000 previously k150594.A review of the device lot history records indicated the device was manufactured to specifications.The documented non-conformance would not have contributed to the reported feedback.A total of ten (10) devices was produced from the lot.A review of the cbi complaint database did not reveal any additional complaints associated with the reported lot number.A review of the ifu revealed that perforation and recurrence are amongst the list of potential complications that "are possible with the use of surgical device materials in otologic procedures." a direct root cause, to the reported perforation persistence and increase in size, is inconclusive.Factors that could contribute to the reported outcome include: patient¿s overall health, lack of viable tissue in area being treated, inadequate blood supply to the repair, graft too small for defect, user technique, and patient post-operative care of the treated area and overall post-op patient activities.The reported worsening of the patient¿s hearing is a secondary effect of the perforation persistence and/or increase in size.
Event or Problem Description
On (b)(6) 2017, dr.(b)(6) implanted an ent-oto-0.6x0.9 for repair of a tympanic membrane perforation.This was a clean and dry procedure.No infection was present at the time of device placement.The perforation was small (under 10%) and centrally located.The device was hydrated and placed in an underlay fashion.Gelfoam was placed in the middle ear and an unspecified ointment was used on the external ear.The tympanic perforation persisted and increased in size.No infection was present, the device degraded / did not remodel, but it was not retrieved.The patient's hearing reportedly worsened from the pre-op state of hearing.The surgeon reported the patient will need another operation.

• Brand Name: BIODESIGN OTOLOGIC REPAIR GRAFT
• Common Device Name: OTOLOGIC REPAIR GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• MDR Report Key: 7183410
• Report Number: 1835959-2018-00001
• Device Sequence Number: 13493746
• Product Code: KHJ
• UDI-Device Identifier: 10827002448398
• UDI-Public: (01)10827002448398(17)181219(10)LB1004103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G44839
• Device Catalogue Number: ENT-OTO-0.6-0.9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GELFOAM AND OINTMENT
• Patient Age: 60 YR