MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-24 for NILE ALTERNATIVE FIXATION 5416-F04730-SG manufactured by K2m, Inc..
[32001741]
A comprehensive investigation was immediately initiated on receipt of the complaint. The subject product has been received and is currently being evaluated. The manufacturer will provide a supplemental report to include the results of the investigation: a review of all applicable material, inspection, manufacturing, and distribution records according to the description of the products used with the concomitant device(s) would be conducted to determine if products lots were manufactured within specifications and distributed in accordance with all operating procedures. A review of the manufacturing and inspection records would be completed looking for any contributing information/trends. A review of the complaint code trends in case they reveal any contributing information as to the cause of this event. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[32001742]
It was reported to k2m, inc. On (b)(6) 2015 that a revision surgery took place in which 5 broken 4mm nile bands were removed. The patient reportedly had 5 nile bands break approximately 3 months post-op. Revision surgery took place (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[33598436]
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 products used with the concomitant device(s) was conducted. All records revealed that all products lots were manufactured within specifications and distributed in accordance with all operating procedures. Based on the delamination of the green fibers present on three of the returned pieces and the reported repositioning of the bands during the original surgery, the subject bands were likely overloaded at the position of the initial tightening. A review of the manufacturing and inspection records did not reveal any contributing information/trends. A review of the complaint code trends did not reveal any contributing information as to the cause of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004774118-2015-00059 |
| MDR Report Key | 5245904 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-03 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2015-11-03 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-11-24 |
| 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 | 2015-11-24 |
| Returned To Mfg | 2015-11-19 |
| Catalog Number | 5416-F04730-SG |
| Lot Number | DHWC |
| Device Expiration Date | 2016-04-09 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-11-24 |