MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-04-05 for PDS PLATE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[104533567]
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Additional information was requested and the following was obtained: does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? The recurrent septal deviation is not a complication from the pds plate but a risk of any septal surgery. There was a septal infection in a (b)(6) yo patient 2 months after placement of pds plate but when we drained the abscess i did not see pds plate remaining. Citation: laryngoscope. 2017; 127. Doi: 10. 1002/lary. 26592 - [(b)(4)-fuller 2017 (1). Pdf].
Patient Sequence No: 1, Text Type: N, H10
[104533568]
It was reported via journal article:? Title: polydioxanone plates are safe and effective for l-strut support in functional septorhinoplasty?. Authors: jennifer c. Fuller, md, patricia a. Levesque, bs, robin w. Lindsay, md. Citation: laryngoscope. 2017; 127. Doi: 10. 1002/lary. 26592. The objectives of this retrospective analysis of a prospective cohort was to evaluate the safety, efficacy, and result stability of polydioxanone (pds) plate use for l-strut stabilization. A total of 88 patients (45 male and 43 female; age range: 8 to 72 years old) with fracture and/or severe deviation of the l-strut underwent functional septorhinoplasty (fsrp) for nasal airway obstruction (nao) for which the pds plate was used for rigid support and were included in the study. A standard open fsrp approach was used for all cases, but one case, in which a 0. 15 mm pds perforated plate was used. In the rest of the cases, a 0. 25 mm non-perforated pds plate were used. The plate was typically cut into an l shape measuring 2 to 3. 5cm dorsally, 1 to 2 cm caudally, and 1 cm in width. The plates were placed along one side of the septum and sutured into place using pds 5-0 suture. The pds plate was used when a septal fracture violated the 1- to 1. 5-cm cartilaginous l-strut and the fracture was not adequately braced with a spreader graft, when there was a persistent concavity or convexity of the dorsal or caudal portion of the l-strut not completely resolved with standard techniques (swinging door, spreader grafts, extended spreader grafts), in patients with persistent deviation of the l-strut after previous septoplasty with limited remaining autologous cartilage for bracing, and in pediatric patients to limit the amount of septal cartilage removed. Reported complications included continued symptomatic nao (n-1) which required revision surgery, a (b)(6)-year-old patient with mild external nasal valve narrowing/collapse and mild internal nasal valve collapse, a (b)(6)-year-old patient with severe right internal nasal valve narrowing which is scheduled for a revision surgery, a (b)(6)-year-old patient with severe right internal nasal valve collapse, and a (b)(6)-year-old patient with moderate dorsal septal deviation, moderate left internal nasal valve narrowing, and severe inferior turbinate hypertrophy. It was concluded that pds plates are safe and effective absorbable material for stabilizing and straightening fractures or severe deviations of the cartilaginous l-strut. There is long-term stability of the clinically and statistically significant improvements in nasal obstruction following functional septorhinoplasty with 0. 25-mm pds beyond the time it takes the plate to resorb. The use of pds plates may also decrease the need for rib grafting in patients with l-strut compromise and a history of previous septoplasty, thereby decreasing patient morbidity and surgical time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-71922 |
| MDR Report Key | 7399649 |
| Report Source | LITERATURE |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDS PLATE UNKNOWN PRODUCT |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2018-04-05 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-05 |