MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-27 for NILE ALTERNATIVE FIXATION SPINAL SYSTEM 5416-F04730-SG manufactured by K2m Inc..
[90516236]
A comprehensive investigation was immediately initiated on receipt of the complaint. A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted. All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures. Given the type of correction and the apparent poor bone quality of the patient, it is likely that the t3 lamina fractured due to the biomechanical loading being applied at that level by the construct. Once the bone fractured, the compression being applied to the laminar hooks was released and the non-ideal contact between the set screws and the rod allowed the laminar hooks to move relative to the rod.
Patient Sequence No: 1, Text Type: N, H10
[90516237]
On 09. 29. 2017 it was reported to k2m, inc. That a revision surgery took place in which broken laminar hooks, bands and set screw were removed. Revision surgery took place on (b)(6) 2017. Related to 3004774118-2017-00158, 3004774118-2017-00169 and 3004774118-2017-00170.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2017-00168 |
| MDR Report Key | 6985338 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-27 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2017-10-27 |
| 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 | MS. SANDRA GILBERT |
| Manufacturer Street | 600 HOPE PARKWAY SE |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal | 20175 |
| Manufacturer Phone | 5719192195 |
| 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 | NILE ALTERNATIVE FIXATION SPINAL SYSTEM |
| Generic Name | BONE FIXATION CERCLAGE |
| Product Code | OWI |
| Date Received | 2017-10-27 |
| Returned To Mfg | 2017-10-16 |
| Catalog Number | 5416-F04730-SG |
| Lot Number | EEKP-22975 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-27 |