OPTIMESH
Received Mar 3, 2017 · Event occurred Feb 15, 2017
Report 2135156-2017-00003 · MDR key 6377254
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Fever
- Pain
- Fever
- Pain
Narrative
Description of Event or Problem
ON (B)(6) 2017, THE PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION WITH PLACEMENT OF A 1500E OPTIMESH IMPLANT. APPROXIMATELY 4 WEEKS FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BACK PAIN AND A FEVER. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR POSTERIOR LUMBAR EXPLORATORY SURGERY AT WHICH TIME THE PHYSICIAN IDENTIFIED AN INFECTION LOCALIZED TO THE INTERVERTEBRAL DISC SPACE. THE OPTIMESH DEVICES WAS REMOVED AND CULTURES WERE TAKEN. A NEW INTERBODY FUSION DEVICE WAS NOT PLACED. MICROBIOLOGICAL RESULTS OF THE CULTURE IDENTIFIED AN ANEROBIC INFECTION CONSISTENT WITH ANAEROBES COMMONLY FOUND IN MUCOSAL MEMBRANES. AT AN UNSPECIFIED TIME FOLLOWING THE RE-OPERATION PROCEDURE, THE PATIENT WAS AGAIN RETURNED TO THE OPERATING ROOM FOR ANTERIOR LUMBAR PLACEMENT OF ANOTHER MANUFACTURER'S INTERBODY FUSION DEVICE.