MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-13 for SU-POR SURGICAL IMPLANTS 4012 manufactured by Poriferous, Llc.
[183373793]
The patient presented with pus and indications of infection following an orbital floor repair using a su-por surgical implant. After intravenous antibiotics were administered, the implant was removed. During re-operation, the physician noticed the maxillary sinus was infected and filled with pus. The surgeon indicated that it did not appear to be an implant infection, but that the implant had been surrounded by pus from the maxillary sinus. The implant was removed as a precaution and replaced with another su-por surgical implant.
Patient Sequence No: 1, Text Type: N, H10
[183373814]
On 02/26/2020, physician communicated signs of infection with implant and advised the patient will be undergoing treatment with antibiotics. Physician communicated that a surgery will be scheduled to remove and replace the infected implant. On 02/28/2020, the physician advised that upon completion of the revision surgery, it was noticed that the infection was present in the maxillary sinus rather than the implant. The implant was removed as a precaution and replaced with another su-por surgical implant on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010781616-2020-00050 |
| MDR Report Key | 9829836 |
| Report Source | FOREIGN |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KRISTA BRADSTREET |
| Manufacturer Street | 535 PINE ROAD SUITE 206 |
| Manufacturer City | NEWNAN, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 6833855105 |
| Manufacturer G1 | PORIFEROUS, LLC |
| Manufacturer Street | 535 PINE ROAD SUITE 206 |
| Manufacturer City | NEWNAN, GA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SU-POR SURGICAL IMPLANTS |
| Generic Name | SU-POR SURGICAL IMPALNT |
| Product Code | KKY |
| Date Received | 2020-03-13 |
| Model Number | 4012 |
| Catalog Number | 4012 |
| Lot Number | 401217070020 |
| Device Expiration Date | 2020-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PORIFEROUS, LLC |
| Manufacturer Address | 535 PINE ROAD SUITE 206 NEWNAN, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |