MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for TRACTION,APPARATUS,NON-POWERED manufactured by Oberdorf Synthes Produktions Gmbh.
[125979916]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 510k: this report is for an unknown distractor /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is 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. Product was not returned. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[125979917]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, an unknown distractor broke. It was unknown when the issue occurred. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-57794 |
| MDR Report Key | 8025596 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-10-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL COTE |
| Manufacturer Street | 3102 WRIGHS 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 | 0 |
| Generic Name | TRACTION,APPARATUS,NON-POWERED |
| Product Code | HST |
| Date Received | 2018-10-31 |
| 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 | 2018-10-31 |