Brand Name | AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC |
Type of Device | SURGICAL INSTRUMENT FOR HIP |
Manufacturer (Section D) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro, switzerland 6874 |
SZ 6874 |
|
Manufacturer (Section G) |
MEDACTA INTERNATIONAL SA |
strada regina |
|
castel san pietro, switzerland 6874 |
SZ
6874
|
|
Manufacturer Contact |
stefano
baj
|
strada regina |
castel san pietro, switzerland 6874
|
SZ
6874
|
|
MDR Report Key | 7726657 |
MDR Text Key | 115534094 |
Report Number | 3005180920-2018-00559 |
Device Sequence Number | 0 |
Product Code |
LXH
|
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/27/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 01.15.10.0261 |
Device Lot Number | 1413789 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/15/2014 |
Initial Date Manufacturer Received |
07/03/2018
|
Initial Date FDA Received | 07/27/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/15/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|