SU-POR SURGICAL IMPLANTS
Received Sep 27, 2023 · Event occurred Jul 25, 2023
Report 3010781616-2023-00105 · MDR key 17825253
Device
Generic name
No Match
Manufacturer
Poriferous, LlcModel number
4028Catalog number
4028
Lot number
402819144054
Product problems
- Off-Label Use
- Off-Label Use
Patient
5 MO · Male
- Wound Dehiscence
- Impaired Healing
- Wound Dehiscence
- Impaired Healing
Narrative
Description of Event or Problem
DURING INITIAL IMPLANTATION, A 14MM SPHERE WAS PLACED AND OPERATING SURGEON DESCRIBED DIFFICULTY SUTURING PATIENTS MUSCLES AND COVING THE IMPLANT WITH ADEQUATE SOFT TISSUE. THE SURGEON ATTEMPTED INTERVENTION THREE TIMES TO INCREASE SOFT TISSUE COVERAGE AND PROMOTE HEALING, BUT WAS UNABLE TO ADEQUATELY COVER THE DEVICE. THE PATIENT HAD PREVIOUSLY UNDERGONE RADIATION THERAPY ON THE SOFT TISSUES AND SURGEON DESCRIBED FAILURE DUE TO FAILURE OF THE SOFT TISSUES. ON JULY 25TH THE 14MM SPHERE WAS EXPLANTED AND A 16MM QUADRO-PORT SPHERE WAS PLACED. THE SURGEON WAS ABLE TO SUTURE THE MUSCLES TO THE REPLACEMENT DEVICE AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.