UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-19 for UNKNOWN manufactured by .

Event Text Entries

[16101216] (b)(6) female admitted for elective surgery on (b)(6) 2010 due to neck pain and bilateral upper extremity pain. On (b)(6) 2010, the pt underwent a c5-c6 and c6-c7 anterior cervical diskectomy and fusion with plating. Pt tolerated the surgery well, without complications. An intraoperative x-ray was taken prior to closing, which showed alignment and no issues. Surgical counts were correct. Post operatively, the pt complaints of spasms with talking and a feeling of choking and gagging. These symptoms did get a little better. Postoperative x-ray and ct scan in (b)(6) 2011, showed a metallic artifact in the superficial soft tissue at the c4-c5 level on the right, on top of the sternocleidomastoid muscle. The pt finally agreed to have the artifact surgically removed. (b)(6). Notice sent to companies that do our facility's instrument repairs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5021831
• MDR Report Key: 2223008
• Date Received: 2011-08-19
• Date of Report: 2011-08-19
• Date of Event: 2011-07-19
• Date Added to Maude: 2011-08-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN
• Generic Name: JAW INSERT IN NEEDLE HOLDER
• Product Code: HXK
• Date Received: 2011-08-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2011-08-19