Brand Name | PROFORM HIP SYSTEM |
Type of Device | ACETABULAR BONE SCREW |
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 | 5906512 |
MDR Text Key | 53093978 |
Report Number | 2530191-2016-00096 |
Device Sequence Number | 1 |
Product Code |
JDO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K934162 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
08/26/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SC2677-35 |
Device Lot Number | 33862260116 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/15/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/08/2016 |
Initial Date FDA Received | 08/26/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/26/2016 |
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 Age | 58 YR |