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 2020-03-16 for SYNFRAME LENGTHENER 387.338 manufactured by Oberdorf Synthes Produktions Gmbh.
[184647394]
(b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. A review of the device history record has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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
[184647395]
"the newly bought synframe extension cannot be connected to the synframe ring which is already available at the hospital. The issue was noted during assembly. No surgery was affected or no patient involvement. " this report for one (1) synframe-extension f/387. 336+387. 337. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01971 |
| MDR Report Key | 9836798 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNFRAME LENGTHENER |
| Generic Name | LAMP, OPERATING ROOM |
| Product Code | FQP |
| Date Received | 2020-03-16 |
| Catalog Number | 387.338 |
| Lot Number | 4L53724 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-16 |