MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-09 for TI FIXATION PLATE F/CONDYLAR HEAD/6MM 04.449.040 manufactured by Synthes Usa.
[4221156]
It was reported that the following event occurred during a secondary mandible resection procedure on (b)(6) 2014. This was a revision of the initial mandible resection surgery, due to a recurrence of cancer. Initial resection surgery was performed on an unknown date. The initial patient specific plate contouring matrix mandible plate and condylar head add-on system were removed. During the revision surgery, the surgeon had difficulty engaging the screws of the condylar add-on plate to the patient specific plate contouring custom implant. Three of the screws stripped, and could not be used. The surgeon had to stop, reassess the bend of the plate and then bend and file the plate a little more in order to the interface between the plate and the custom implant so that the screws would engage the implant. Another set was opened for additional screws. The procedure was prolonged by 25 minutes to manipulate the plate and secure additional screws to complete the procedure. Patient was stable following the revision surgery. There is no allegation of deficiency against part sd449. 511b (titanium implant patient specific plate contouring matrix mandible 7x23h angle recon pl/right/2. 5mm) and part 04. 449. 000 (titanium condylar head). This is 4 of 4 reports for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11813254]
Device was used for treatment, not for diagnosis. Implant date: unknown. Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[19095453]
Additional narrative: 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
[22206613]
Device was used a treatment, not diagnosis additional narrative: manufacturer: reported as (b)(4) on the initial medwatch without a lot number provided. Not implanted. 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 | 1000562954-2014-10043 |
| MDR Report Key | 3737670 |
| Report Source | 05,07 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-03-24 |
| Date Mfgr Received | 2014-07-09 |
| Date Added to Maude | 2014-06-03 |
| 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 G1 | SYNTHES MEZZOVICO |
| Manufacturer Street | ZONA INDUSTRIALE 4 |
| Manufacturer City | MEZZOVICO CH6805 |
| Manufacturer Country | US |
| Manufacturer Postal Code | CH6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI FIXATION PLATE F/CONDYLAR HEAD/6MM |
| Generic Name | PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY |
| Product Code | NEI |
| Date Received | 2014-04-09 |
| Catalog Number | 04.449.040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 19380CH6 US 19380 CH68 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-09 |