Brand Name | PRODISC C MILLING BIT WITH 2.35MM X 33.5MM SHAFT |
Type of Device | BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE |
Manufacturer (Section D) |
CENTINEL SPINE, LLC. |
900 airport rd, suite 3b |
west chester, pa |
|
Manufacturer (Section G) |
TECOMET INC. |
5307 9th avenue |
|
kenosha, wi |
|
Manufacturer Contact |
jason
smith
|
2001 n. congress ave. |
riveria beach, FL 33404
|
8878839
|
|
MDR Report Key | 9823383 |
MDR Text Key | 188001324 |
Report Number | 3007494564-2020-00014 |
Device Sequence Number | 1 |
Product Code |
GFG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/16/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/12/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 03.820.157 |
Device Lot Number | 2019-0398 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/09/2020 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/18/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/14/2019 |
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) |
Required Intervention;
|
Patient Age | 48 YR |
Patient Sex | Male |