MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE AND ABUTMENT; LXB: PRODUCT CODE

Catalog Number 93330

Device Problem Loss of Osseointegration (2408)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of osseointegration (date not reported) resulting in fixture loss.The patient was reimplanted with another device on (b)(6) 2015.The device is not available for analysis.

Manufacturer Narrative

(b)(4).Device is not available for analysis.

• Brand Name: BAHA FLANGE AND ABUTMENT
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4484042
• MDR Text Key: 5568002
• Report Number: 6000034-2015-00202
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 01/12/2015

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
• Device Operator: Other
• Device Catalogue Number: 93330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention