MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-06 for NILE ALTERNATIVE FIXATION 5416-F04730-SG manufactured by K2m, Inc..
[41990514]
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. Evaluation in process.
Patient Sequence No: 1, Text Type: N, H10
[41990515]
It was reported to k2m, inc on (b)(6) 2016 that a revision surgery took place in which a band fractured post-op. Revision surgery took place (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[44579404]
A comprehensive investigation was immediately initiated on receipt of the complaint. A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted. All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures. A review of the manufacturing and inspection records did not reveal any contributing information/trends. Based on the twisting and fraying observed on the band, it was likely overloaded at the position of the clamp/anatomy interface.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004774118-2016-00015 |
| MDR Report Key | 5551444 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-11 |
| Device Manufacturer Date | 2015-07-21 |
| Date Added to Maude | 2016-04-06 |
| 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 | 751 MILLER DR SE SUITE F-1 |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal | 20175 |
| Manufacturer Phone | 5719192000 |
| Manufacturer G1 | K2M, INC. |
| Manufacturer Street | 751 MILLER DR SE SUITE F1 |
| 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 |
| Generic Name | BONE FIXATION CERCLAGE |
| Product Code | OWI |
| Date Received | 2016-04-06 |
| Returned To Mfg | 2016-03-29 |
| Catalog Number | 5416-F04730-SG |
| Lot Number | DHWD |
| 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 | 751 MILLER DR SE SUITE F1 LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-06 |