MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-12-15 for PDS PLATE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[95024055]
Product complaint # (b)(4). (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Citation: british journal of oral and maxillofacial surgery 51 (2013) e224? E229. Http://dx. Doi. Org/10. 1016/j. Bjoms. 2013. 01. 016.
Patient Sequence No: 1, Text Type: N, H10
[95024056]
It was reported in journal article? Secondary correction of posttraumatic orbital wall adhesions by membranes laminated with amniotic membrane? That the objective of this study was to find out if human amniotic membrane could be used for corrective surgery after trauma to the orbit wall. The patient with defective motility of the bulb after fractures of the orbital floor was treated and had the orbital wall repaired and polydioxanone foil was used. Treatment of large blow-out fractures with foil can lead to adhesions and scars, resulting in reduced motility of the bulb and diplopia. The patient inserted with polydioxanone foil and titanium mesh experienced minor restriction of up gaze with diplopia on up gaze. Secondary correction involved detachment of adhesions and scars, removal of polydioxanone foil, and insertion of amniotic membrane laminated polyglactin910/polydioxanone patch. The outcome after 3 months was full range of motility of bulb and no diplopia. Additional information will be requested.
Patient Sequence No: 1, Text Type: D, B5
[106196716]
(b)(4). Date sent to the fda: 02/08/2018 the following additional information was requested but unavailable: were the cases discussed in this article previously reported? Why does the author believe that the suture contributed to the event and not the titanium mesh?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2017-71830 |
| MDR Report Key | 7122781 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-12-15 |
| Date of Report | 2017-11-28 |
| Date Mfgr Received | 2018-02-08 |
| Date Added to Maude | 2017-12-15 |
| 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 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 | 2017-12-15 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-15 |