| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PDS PLATE UNKNOWN PRODUCT | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE | ETHICON INC. | NHB | UNK | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-12-19 | 0 | 1. R |
Patient 1
PRODUCT COMPLAINT # (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. CITATION: ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY 2017, VOL. 126(10) 688? 692. HTTPS://DOI.ORG/10.1177/0003489417727.
Patient 1
IT WAS REPORTED IN A JOURNAL ARTICLE (TITLE: POSTOPERATIVE NASAL SEPTAL ABSCESS FOLLOWING USE OF 2-OCTYLCYANOACRYLATE AND POLYDIOXANONE PLATE IN OPEN SEPTORHINOPLASTY) THAT A PATIENT UNDERWENT A PRIMARY OPEN SEPTORHINOPLASTY WITH PLACEMENT OF AN AUTOLOGOUS CAUDAL SEPTAL EXTENSION GRAFT ON AN UNKNOWN DATE AND AN ABSORBABLE IMPLANT WAS USED. A SMALL STRIP OF ABSORBABLE PLATE WAS AFFIXED WITH TOPICAL SKIN ADHESIVE TO THE CEPHALIC PORTION OF THE GRAFT, WHICH WAS SUBSEQUENTLY SEWN IN PLACE WITH SUTURE. FOLLOWING AN UNCOMPLICATED COURSE, PATIENT PRESENTED ON POSTOPERATIVE WEEK 5 WITH A LEFT-SIDED SEPTAL ABSCESS EXTENDING TO THE NASAL TIP AND COLUMELLA. INCISION AND DRAINAGE WAS PERFORMED WITH CULTURE (PROTEUS MIRABILIS) DIRECTED ANTIBIOTICS. DESPITE AGGRESSIVE MEDICAL MANAGEMENT TO INCLUDE DAILY WOUND IRRIGATION AND PACKING, THE PATIENT WAS RETURNED TO THE OPERATING ROOM 2 WEEKS FROM INITIAL ABSCESS PRESENTATION, AND THE ABSORBABLE IMPLANT WAS REMOVED. CULTURES OBTAINED AT TIME OF REMOVAL WERE POSITIVE FOR PROTEUS MIRABILIS DESPITE 2 WEEKS OF AGGRESSIVE WOUND CARE AND SENSITIVITY-SPECIFIC ANTIBIOTIC THERAPY. FOLLOWING REMOVAL OF THE IMPLANT, THE PATIENT?S INFECTION RESOLVED OVER THE FOLLOWING WEEK; HOWEVER, THE PATIENT SUSTAINED SIGNIFICANT COLUMELLA CONTRACTION AND LOSS OF TIP SUPPORT. ADDITIONAL INFORMATION WILL BE REQUESTED.