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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

The device is currently unavailable.

Event Description

Per the clinic, the patient experienced recurrent skin overgrowth and irritation at the abutment site.On (b)(6) 2015, the patient underwent a procedure to repair the scalp and layer closure.Subsequently on (b)(6) 2016, the device was explanted.

Manufacturer Narrative

Correction; the device was not explanted (b)(6) 2016 as previously reported, the implanted device remains.The implanted device remains.

Manufacturer Narrative

Correction: the correct catalog # is 93332; not 93329 as previously reported.Correction: the device was explanted on (b)(6) 2016.The explanted device is not available for analysis.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB, PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke SE 43 5-22; SW SE 435-22
• Manufacturer Contact: nicole hille ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5692040
• MDR Text Key: 46313381
• Report Number: 6000034-2016-01098
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• 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: 93332
• Device Lot Number: 159411151582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• 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: 59 YR