Brand Name | CD HORIZON SPINAL SYSTEM |
Type of Device | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Manufacturer (Section D) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
|
humacao PR 00792 |
|
Manufacturer Contact |
glen
belmer
|
1800 pyramid place |
memphis, TN 38132
|
6122713209
|
|
MDR Report Key | 13937700 |
MDR Text Key | 288092971 |
Report Number | 1030489-2022-00294 |
Device Sequence Number | 1 |
Product Code |
KWP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113174 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/29/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/29/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 5540030 |
Device Catalogue Number | 5540030 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/03/2022 |
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;
|
Patient Age | 15 YR |
Patient Sex | Female |
Patient Weight | 59 KG |
Patient Race | White |
|
|