PYRAMESH® IMPLANT SYSTEM
Received Jul 17, 2014 · Event occurred Jun 23, 2014
Report 1030489-2014-03256 · MDR key 3941904
Device
Generic name
Mesh, Metal
Manufacturer
Medtronic Sofamor DanekModel number
NACatalog number
G905H103
Lot number
UNK
Product problems
- Migration or Expulsion of Device
Patient
00066 YR
- Dysphagia/ Odynophagia
- Neurological Deficit/Dysfunction
Narrative
Additional Manufacturer Narrative
(B)(6). (B)(4). DYSPHAGIA. NEUROLOGICAL DEFICIT/DYSFUNCTION. MIGRATION OF DEVICE OR DEVICE COMPONENT. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 905-103 AND 510K # K890601 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL SPINAL FUSION AND CORPECTOMY AT C4, C5 AND C6. ON AN UNSPECIFIED DATE POST-OPERATIVELY, IT WAS FOUND THAT THE ROUND TITANIUM MESH IMPLANT "MOVED FRONTAL". PATIENT ALSO REPORTEDLY DEVELOPED DYSPHAGIA AND NEUROLOGICAL SYMPTOMS AND THE PATIENT WAS PRESCRIBED A CERVICAL COLLAR. A REVISION SURGERY WAS PERFORMED AND ACCORDING TO THE REPORT, THE IMPLANT "WAS REPLACED WITH A NEW ONE". AFTER THE REVISION SURGERY, THE PATIENT WAS PRESCRIBED A HALO VEST. NO INFORMATION REGARDING HEALTH INJURY WAS REPORTED.