MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abscess (1690)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.On (b)(6) 2015, the patient was taken to the operating room and administered general anesthesia to facilitate an abutment exchange.Subsequently, the patient developed an abscess at the abutment site.On (b)(6) 2015 the site was drained and the patient was prescribed oral antibiotics.The patient continued to experience skin issues at the abutment site, resulting in skin debridement on (b)(6) 2015 with the removal of the abutment on (b)(6) 2015.The implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, se 435-2 2; SW 435-22
• Manufacturer Contact: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5320344
• MDR Text Key: 34171526
• Report Number: 6000034-2015-02584
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2015

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 92134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR