Brand Name | PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL) |
Type of Device | HXB |
Manufacturer (Section D) |
ALPHATEC SPINE, INC. |
5818 el camino real |
carlsbad CA 92008 |
|
Manufacturer Contact |
richard
younger
|
5818 el camino real |
carlsbad, CA 92008
|
7604946842
|
|
MDR Report Key | 8046555 |
MDR Text Key | 126644741 |
Report Number | 2027467-2018-00078 |
Device Sequence Number | 1 |
Product Code |
HXB
|
UDI-Device Identifier | 00840967190112 |
UDI-Public | (01)00840967190112(10)7527004 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
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 |
10/17/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/07/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 22SPT10 |
Device Catalogue Number | 22SPT10 |
Device Lot Number | 7527004 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/19/2018 |
Date Manufacturer Received | 10/17/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/24/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|