Brand Name | 10G CURETTE |
Type of Device | SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
* 00615 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
*
00615
|
|
Manufacturer Contact |
zach
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 11218301 |
MDR Text Key | 229321676 |
Report Number | 0001811755-2021-00326 |
Device Sequence Number | 1 |
Product Code |
OCJ
|
UDI-Device Identifier | 07613252574187 |
UDI-Public | 07613252574187 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/22/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 0306620000 |
Device Catalogue Number | 0306620000 |
Device Lot Number | VMSR |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/31/2020
|
Initial Date FDA Received | 01/22/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|