MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for POLYAXIAL SCREW; SIZE ?4.5X30 MM 7601-04530 manufactured by K2m, Inc..
[183768789]
Device evaluation anticipated.
Patient Sequence No: 1, Text Type: N, H10
[183768790]
Physician reported that 2 yukon oct spinal system polyaxial screws; size? 4. 5x30 mm fractured at the neck of the shaft post-operatively. Revision surgery was performed. This report captures the second of two screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2020-00027 |
| MDR Report Key | 9821386 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RITA KARAN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | K2M, INC. |
| Manufacturer Street | 600 HOPE PARKWAY SE |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYAXIAL SCREW; SIZE ?4.5X30 MM |
| Generic Name | POSTERIOR CERVICAL SCREW SYSTEM |
| Product Code | NKG |
| Date Received | 2020-03-11 |
| Model Number | 7601-04530 |
| Catalog Number | 7601-04530 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | K2M, INC. |
| Manufacturer Address | 600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |