| Brand Name | 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 40MM |
|---|
| Common Device Name | 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 40MM |
|---|
| Manufacturer (Section D) |
| ORTHOPEDIATRICS, CORP |
| 2850 frontier drive |
| warsaw IN |
|
|---|
| Manufacturer (Section G) |
| ORTHOPEDIATRICS, CORP |
| 2850 frontier drive |
|
| warsaw IN |
|
|---|
| Manufacturer Contact |
|
james
gunnels
|
| 2850 frontier drive |
| warsaw, IN
|
|
|---|
| MDR Report Key | 21147667 |
|---|
| Report Number | 3006460162-2025-00003 |
|---|
| Device Sequence Number | 18439238 |
|---|
| Product Code |
NKB
|
| UDI-Device Identifier | 00841132101315 |
|---|
| UDI-Public | 00841132101315 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter Country | AS |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Device Implanted Year | 2023 |
|---|
| Device Explanted Year | 2024 |
|---|
| Serviced by Third Party (Y/N) | Unknown |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Company Representative |
|---|
| Initial Reporter Occupation |
Other
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
01/14/2025 |
|---|
| 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 Catalogue Number | 00-1300-2640 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Type of Report(Section G) | Thirty-Day |
|---|
| Initial Date Received by Manufacturer | 12/15/2024 |
|---|
| Initial Report FDA Received Date | 01/14/2025 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Unknown
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Age | 15 YR |
|---|
| Patient Sex | Female |
|---|
| Patient Weight | 32 KG |
|---|
|
|
