MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-18 for NILE ALTERNATIVE FIXATION SPINAL SYSTEM 5401-85500 manufactured by K2m, Inc..
[60423828]
A comprehensive investigation was immediately initiated on receipt of the complaint. The subject product was returned for evaluation but evaluation is still in progress. Upon completion of evaluation of the subject part, k2m inc. Will file a supplemental report indicating the findings.
Patient Sequence No: 1, Text Type: N, H10
[60423829]
On 10/19/2016 it was reported to k2m, inc. That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss. Lamina fracture was noticed at the level of issue. Surgery took place (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[63454718]
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. The reported difficulty in inserting the set screw was likely caused by the clamp being implanted and explanted multiple times. The fractured lamina of the patient was likely caused by the multiple attempts of tensioning and loosening the clamp on the lamina. Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.
Patient Sequence No: 1, Text Type: N, H10
[63454719]
On 10/19/2016 it was reported to k2m, inc. That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss. Lamina fracture was noticed at the level of issue. After repeated removals and replacement there was difficulty inserting one of the set screws. Surgery took place (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2016-00094 |
| MDR Report Key | 6113646 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-18 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-11-18 |
| 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 | 5719192000 |
| 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 | 2016-11-18 |
| Returned To Mfg | 2016-10-21 |
| Catalog Number | 5401-85500 |
| Lot Number | EPAH |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-11-18 |