MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-07-31 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 1620 manufactured by Dfine Inc..
[23354198]
The product has not been received within our facility for evaluation. Upon receipt, final evaluation will be conducted and a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[23354199]
Per received report: during procedure, the midline osteotome (mlo) was inserted and made 1 (one) pass. The bone was reported to have not been dense or sclerotic. The midline osteotome was difficult to remove and came out completely bent. The physician did not attempt to make another pass. One channel was made for cavity creation and the cement was eventually delivered. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[29983149]
The customer reported event of the midline osteotom (mlo) being difficult to remove and came out completely bent could not be confirmed. However, investigation revealed the tip had a minor bend which is similar to devices that encountered dense or hard bone during use. The device's distal end is flexible, bending out of stability introducer during deployment. Although the tip sustained minor bend, the concentration of stress at its bend exhibited adequate strength to withstand insertion and removal from cancellous bone when placed through an introducer with no breakage sustained under force. The device was safely withdrawn. Although there does not appear to be any indication of product quality deficiency, a definitive cause for the reported issue cannot be determined. All units are 100% inspected and tested for its functionality during the manufacturing process and only passing units are moved to the next process. Additionally, a sampling of units is destructively tested to verify the midline osteotome's integrity. A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00010 |
| MDR Report Key | 4993201 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2015-05-21 |
| Date Added to Maude | 2015-08-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN BALBIERZ |
| Manufacturer Street | 30478 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-07-31 |
| Returned To Mfg | 2015-08-17 |
| Model Number | NA |
| Catalog Number | 1620 |
| Lot Number | 150521 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |