MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-10-07 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME N/A 1620 manufactured by Dfine Incorporated.
[27817141]
The product has not been returned for evaluation. As soon as the device is received, a final analysis will be performed and a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[27817142]
Per received report: the patient has a history of metastatic non-small cell lung cancer (stage 4), atrial fibrillation, htn, copd. During cavity creation, the outer sheath of the midline osteotome (mlo) got stuck and remained in the vertebral body. An on-control drill (manufactured by another company) was used to drill through the introducer and through the outer sheath of midline osteotome. The tip of the sheath of the mlo broke off and was unretrievable. The remainder of the sheath was removed. Cement was put into the vertebral body around the portion left in the vertebral body. A call was made on (b)(6) 2015 to see how the patient is doing. The patient is doing well. There were some procedural pain at the site (b)(6) in pain scale. On (b)(6) 2015, patient stated that her low back pain was gone and she was doing well, she has then increased activity and taking no pain medication.
Patient Sequence No: 1, Text Type: D, B5
[32664888]
The customer reported event of the midline osteotome's outer sheath getting stuck in the vertebral body during cavity creation was confirmed. Per product specification, the outer sheath's total length is 126mm. The remaining outer sheath that was received was measured at 102. 4mm. Therefore, approximately 23. 6mm of the broken tip of the outer sheath could have been left and remained in the vertebral body. The device's distal end is flexible, bending out of stability introducer when deploying. The failure mode and the acute bend observed upon receipt, though definitive cause could not be determined, is similar to the devices that encounter dense or hard bone while being advanced from the tip of the introducer. This is evident of the damage observed on the unit upon receipt. Instruction for use (ifu) 3290 cautions that "the device is not to be used in dense bone". Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined. All units are 100% visually inspected and tested for its functionality during the manufacturing process. Additionally, a sampling of units is destructively tested to verify the midline osteotome's (mlo) integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00013 |
| MDR Report Key | 5132360 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-09-08 |
| Device Manufacturer Date | 2015-05-07 |
| Date Added to Maude | 2015-10-07 |
| 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 | MR. DANIEL BALBIERZ |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4087701150 |
| Manufacturer G1 | DFINE INCORPORATED |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2015-10-07 |
| Returned To Mfg | 2015-11-19 |
| Model Number | N/A |
| Catalog Number | 1620 |
| Lot Number | M209639 |
| Device Expiration Date | 2015-05-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INCORPORATED |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-07 |