MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-20 for PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE manufactured by Oberdorf Synthes Produktions Gmbh.
[111651657]
This information is unknown. Date of infection is unknown. This report is for an unknown synpor implant/unknown lot. Part and lot numbers are unknown; udi number is unknown. Date of implantation is unknown date between 2003 and 2013. Date of explantation is unknown date 6 months after implantation. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[111651658]
This report is being filed after the review of the following journal article. Jung b. K. Et al (2016) orbital floor reconstruction using a tensor fascia lata sling after total maxillectomy. Journal of cranio-maxillo-facial surgery. Volume 44. Pages 648-653. (korea, south) the aim of this study is to present the outcomes of orbital floor reconstruction using tensor fascia lata slings after total maxillectomy and to compare these results to orbital floor reconstruction using alloplastic implants. Between 2003 and 2013, 19 patients (12 males and 7 females with mean age of 56 years) who underwent maxillectomy with orbital floor removal for malignancies and subsequent reconstruction were retrospectively analyzed. Five patients had orbital floor reconstructions with tensor fascia lata slings (group a), and 14 patients had reconstructions with alloplastic implants (group b). Out of the 14 patients in group b, two were implanted with an unknown synthes ultra-high molecular weight polyethylene. The mean follow-up was 57 months. A (b)(6) male had signs of infection in the inferior orbital area plate exposure after 4 months. After 6 months, the plate was removed and the orbital floor was reconstructed with a reverse temporalis muscle flap and rib bone grafts. The patient recovered well, but the tumor recurred in the supero-temporal orbital area after the initial surgery. The following complications were reported in patients under group b. In this group, patients were implanted with either an alloplastic implant or with an unknown synthes synpor? : 13 cases of wound complications, 1 case of infection, 3 cases of plate exposure, 4 cases of infection. Five (5) cases of plate exposure: 3 cases of enophthalmos, 9 cases of ectropion, 8 cases of re-operation. This report is for an unknown synthes synpor?. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-54430 |
| MDR Report Key | 7618974 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-24 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-06-20 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-20 |