MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,07 report with the FDA on 2015-02-26 for INSTRUMENT, BENDING OR CONTOURING manufactured by Synthes Usa.
[15119667]
This report is being filed after the subsequent review of the following abstract: "plate exposure after anterolateral thigh free-flap reconstruction in head and neck cancer patients with composite mandibular defects" (2015). Fanzio p. M. Et al. Taiwan article. Between january 2007 and june 2012, 1,452 patients who underwent free tissue transfer after head and neck cancer ablation were retrospectively reviewed. The study focused on the predictive risk of plate exposure. The study enrolled 123 men and 7 women. A titanium mandibular reconstruction system (synthes, inc. , (b)(4)) was used to bridge the mandibular defects. Out of 123 men, post-operative plate exposure occurred for 49 men (age range - 55. 3? 10. 0) and 74 men (age range - 56. 7? 13. 6) had no post - operative plate exposure. 36 patients with non exposed plates developed post operative wound infection and 21 patients with exposed plates developed post operative wound infection. This is report 1 of 1 for (b)(4). This report is for unknown (cmf) mandibular reconstruction system. A copy of the journal article is being submitted with this medwatch. This report is for 1 device.
Patient Sequence No: 1, Text Type: D, B5
[15472563]
Device was used for treatment, not diagnosis. Date of event: "plate exposure after anterolateral thigh free-flap reconstruction in head and neck cancer patients with composite mandibular defects" (2015). Fanzio p. M. Et al. Taiwan article. This report is for an unknown mandibular reconstruction system / unknown quantity / unknown lot. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. 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
| Report Number | 2520274-2015-11217 |
| MDR Report Key | 4551089 |
| Report Source | 01,03,07 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-02-03 |
| Date Added to Maude | 2015-02-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-26 |