MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-09-21 for UNKNOWN manufactured by K2m, Inc..
[55215975]
On 08/22/2016 k2m, inc. Received a copy of the user report (b)(4) from (b)(6). K2m, inc. Has been unable to determine the product to which this report pertains, as the report did not provide a part or lot number and the product has not been returned. We have made several attempts to contact the initial reporter in an effort to obtain further identifying information regarding the product, to no avail. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained, k2m inc. Will file a supplemental report indicating the findings.
Patient Sequence No: 1, Text Type: N, H10
[55215976]
On 08/22/2016 k2m, inc. Received a copy of the user submitted report which stated: event desc: double bladed knife handle used to dissect through soft tissue and bone. Small portion of tip broke off and was non-retrievable. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2016-00077 |
| MDR Report Key | 5965890 |
| Report Source | OTHER |
| Date Received | 2016-09-21 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-07-08 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | HTS |
| Date Received | 2016-09-21 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2016-09-21 |