MAUDE MDR 2223008

MDR report key
2223008
Report number
MW5021831
Event key
0
Event type
3
Date of event
2011-07-19
Date received
2011-08-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWNJAW INSERT IN NEEDLE HOLDERHXK N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-08-1901. O

Event Narratives#

D

Patient 1

(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.