Brand Name | PROVIDENT HIP SYSTEM |
Type of Device | APICAL THREADED PROVIDENT SHELL |
Manufacturer (Section D) |
STELKAST INC. |
200 hidden valley road |
mcmurray PA 15317 |
|
Manufacturer (Section G) |
STELKAST INC. |
200 hidden valley road |
|
mcmurray PA 15317 |
|
Manufacturer Contact |
john
reyher
|
200 hidden valley road |
mcmurray, PA 15317
|
7249416368
|
|
MDR Report Key | 8264278 |
MDR Text Key | 133700854 |
Report Number | 2530191-2019-00001 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K935484 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/21/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/21/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SC3546-52 |
Device Lot Number | 31234-060414 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/11/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/04/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|