MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANTS; SU-POR SURGICAL IMPALNT

Model Number	4012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Infection, Pyrogenic (2246)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SU-POR SURGICAL IMPLANTS
• Common Device Name: SU-POR SURGICAL IMPALNT
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine road; suite 206; newnan, ga
• MDR Report Key: 9829836
• Report Number: 3010781616-2020-00050
• Device Sequence Number: 10947933
• Product Code: KKY
• UDI-Device Identifier: 00815285020120
• UDI-Public: 00815285020120
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K140437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: 4012
• Device Catalogue Number: 4012
• Device Lot Number: 401217070020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 95