MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-15 for NILE ALTERNATIVE FIXATION SYSTEM 5401-84500H manufactured by K2m, Inc..
[59858048]
A comprehensive investigation was immediately initiated on receipt of the complaint. The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case. Since the clamp was disposed of at the hospital, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained. The difficulty with the nile clamp is consistent with improper technique. Tightening a set screw on a band and repositioning can cause stress risers in the band. While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information. Hospital disposed of device.
Patient Sequence No: 1, Text Type: N, H10
[59858049]
It was reported to k2m, inc. On (b)(6) 2016 that a surgery took place on (b)(6) 2016 in which a nile clamp did not work as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2016-00095 |
| MDR Report Key | 6101512 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-16 |
| Date of Event | 2016-10-14 |
| Date Mfgr Received | 2016-10-16 |
| Date Added to Maude | 2016-11-15 |
| 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 SYSTEM |
| Generic Name | BONE FIXATION CERCLAGE |
| Product Code | OWI |
| Date Received | 2016-11-15 |
| Catalog Number | 5401-84500H |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| 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 | 2016-11-15 |