MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-01-25 for DELTA TWIST 4R120 manufactured by Otto Bock Healthcare Products Gmbh.
[98164579]
Device is currently not available for evaluation (not returned from the customer yet); supplemental report will be submitted after evaluation of all device components is completed.
Patient Sequence No: 1, Text Type: N, H10
[98164580]
This component was damaged in a motorcycle accident on (b)(6) 2017. Customer attempted to service it but was unable to get good results: rotation feature is stuck. Compression - unable to adjust. This job came in with another, a 3r60 - modular polycentric ebs knee joint (also returned on notification 600507558: "client was involved in a motorcycle accident (b)(6) 2017. Four bolts in knee came loose and 2 fell out completely. Frame seems to have been twisted. Unable to install bolts again. ") related to the same motorcycle accident. While the customer indicated the 4r120 was not the cause of the fall, they are indicating that the 3r60 was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2018-00007 |
| MDR Report Key | 7217992 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-01-25 |
| Date of Report | 2018-02-07 |
| Date of Event | 2017-07-15 |
| Date Mfgr Received | 2018-02-02 |
| Device Manufacturer Date | 2010-10-13 |
| Date Added to Maude | 2018-01-25 |
| 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. REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Manufacturer Phone | 1 5233786 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA TWIST |
| Generic Name | EXTERNAL ANKLE/FOOT PROSTHESIS |
| Product Code | ISH |
| Date Received | 2018-01-25 |
| Returned To Mfg | 2018-01-25 |
| Model Number | 4R120 |
| Catalog Number | 4R120 |
| Lot Number | 0012201041 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, VIENNA 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-01-25 |