MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MM 8801-04016DA manufactured by K2m, Inc..
[184161408]
Device remains implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[184161409]
A physician reported two fractured ozark screws at the c6 level. Revision status is not currently known but patient is reportedly symptomatic. This report represents the second of two screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2020-00050 |
| MDR Report Key | 9855332 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| 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 | SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-19 |
| Model Number | 8801-04016DA |
| Catalog Number | 8801-04016DA |
| 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 | 2020-03-19 |