PYRAMESH C TITANIUM MESH
Received Dec 20, 2019
Report 1030489-2019-01445 · MDR key 9500883
Device
Generic name
Mesh, Metal
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
905-137
Lot number
0250974W
Product problems
- Break
- Loosening of Implant Not Related to Bone-Ingrowth
- Break
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IMPLANTED DATE: ONLY YEAR VALID. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED AS PER A LITIGATION COMPLAINT THAT ON AN UNKNOWN DATE IN 2013, THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL INJURY CAUSED FROM AN ACCIDENT IN THE SCHOOL. ALLEGEDLY, A CERVICAL VERTEBRA WAS SURGICALLY IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE IMPLANT WAS FOUND BROKEN AND LOOSENED. NO MORE INFORMATION IS AVAILABLE NOW.