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 2019-01-30 for TI FIXATION PLATE F/CONDYLAR HEAD/2MM 04.449.020 manufactured by Oberdorf Synthes Produktions Gmbh.
[134521542]
Explanted date: device has not been reported as explanted. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. A review of the device history records has been requested. 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
[134521543]
Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2018 a two (2) titanium condylar heads and a slotted screw for conylar head did not fit properly with the patient specific plate for mandible. The surgeon noticed from his last surgery that there was an offset between the plate and the condylar head after fixation with the screws. The screws only did a small rotation to be locked in their position, hence the plate was not well in contact with the condyle. There was no surgical delay reported and did not cause injury or harm to the patient. This report is for a titanium condylar head. This is report 1 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60487 |
| MDR Report Key | 8289282 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-30 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2019-01-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI FIXATION PLATE F/CONDYLAR HEAD/2MM |
| Generic Name | PROSTHESIS, CONDYLE, MANDIBULAR TEMPORARY |
| Product Code | NEI |
| Date Received | 2019-01-30 |
| Catalog Number | 04.449.020 |
| Lot Number | L621613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-30 |