MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN OTOLOGIC REPAIR GRAFT

Model Number	G44451
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unspecified by the complainant.510(k): k161000.No evaluation code desc: no device was returned to the manufacturer.Device may have been partially explanted and discarded or submitted to pathology.Some portion of the device remained implanted in the patient.Investigation into this feedback included: a review of the feedback details, a review of the device lot history record, a review of the cbi complaint database, and a review of the biodesign otologic repair graft ifu fp0108-01.No device was returned to the manufacturer.Device may have been partially explanted and discarded or submitted to pathology.Some portion of the device remained implanted in the patient.A review oft he device lot history record revealed there were no nonconformances or deviations associate with the lot.The device was manufactured to specifications.A quantity of ten (10) device was produced from the lot.A review of the cbi complaint database did not review any additional complaints associated with the reported lot number.The ifu does note inflammation, cholesteatoma, squamous cysts, and thickening of the tympanic membrane amongst the list of potential complications.The root cause, of the possible reaction to the graft, is inconclusive.The pathology results were not provided to the manufacturer and therefore a possible reaction to the graft can neither be confirmed nor ruled out.Procedure specific details were also not provided to the manufacturer.It is unknown what additional devices, products, or medications were used during the initial surgery.Details relating to the surgeons technique were also not available to the manufacturer.
Event or Problem Description
On (b)(6) 2019, dr.(b)(6) implanted a biodesign otologic repair graft for a right tympanoplasty.At an unspecified time post op, the patient was believed to have had a reaction to the graft in which a mass was present.The mass was in the external auditory canal (eac) to the middle ear.The patient underwent an exploratory tympanoplasty for removal of the mass.The mass was sent to pathology.The graft was not removed in full as doing so would have resulted in a partial ear canal and ear drum resection.The patient was treated with ciprodex (antibiotic) packing.The pathology was reportedly consistent with a possible reaction to the graft.However, pathology results were not available to the graft manufacturer.

• 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: 9188094
• Report Number: 1835959-2019-00004
• Device Sequence Number: 10839176
• Product Code: KHJ
• UDI-Device Identifier: 10827002444512
• UDI-Public: (01)10827002444512(17)200415(10)LB1095593
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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 Expiration Date: 04/15/2020
• Device Model Number: G44451
• Device Catalogue Number: ENT-OTO-2.5X2.5
• Device Lot Number: LB1095593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention