MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-01-09 for VERTECOR MIDLLINE OSTEOTOME 3.0 3353 manufactured by Dfine Inc..
[5170879]
The pt had previously undergone radiation therapy suggesting that the pt could have had sclerotic dense bone, predisposing the midline osteotome to becoming embedded in the pt's sacrum. The significant sclerotic nature of the bone was further confirmed when the physician was required to use a mallet to drive the mlo into position. Upon numerous attempts to withdraw the mlo from the working cannula, the mlo was removed in conjunction with the working cannula resulting in a portion of the distal end of the inner and middle tubes as well as the entire length of the outer tube remaining lodged in the pt. Removal of all but the portion embedded in the sacrum itself was achieved when the distal end of the outer tube fractured upon applying traction with a large forcep to that portion exposed through the skin. No further surgical incision was required and no component of the device remained in soft tissue. The sacrum was then augmented with pmma cement immobilizing that portion of the mlo minimizing risk associated with the portion of the device remaining in the pt. The physician confirmed no add'l incision was required to remove the extraosseous portion of the mlo initially stuck in the pt. The pt was doing well approx one week post-procedure. The procedure resulted in reduction in the pt's pain and there were no untoward effects to the distal tip of the mlo implanted in the pt. The mlo appears to have been used in sclerotic dense bone. The product ifu contains a warning against use of the mlo in dense sclerotic bone. After speaking with physician, it is clear that pt harm was not alleged, and is unlikely based on the fact that no soft tissue injury occurred. No add'l surgical intervention was required in the retrieval of the lodged device, that portion of the device that was unable to be removed was completely embedded within the confines of the vertebra as well as interdigitated with pmma bone cement during the augmentation procedure and is manufactured of medical grade 316 stainless steel, a material commonly used in orthopedic implants with good biocompatibility profile.
Patient Sequence No: 1, Text Type: D, B5
[12752112]
Dhr review: stabilit first fracture kit, short blister pack, lot @ 141124a02 (qty (b)(4)), pn 3353; first fracture kit, blister pack sterile, short devices, lot # m208406, pn 3352 (midline sub-assembly short, pn39-03969-002-50, lot # m208371 and m208293); qpi 2803, end item audit testing, frm2857, (b)(4) qty accepted. No anomaly was revealed that was in relation to the complaint (b)(4). Eval of device: a review of the material specifications (b)(4), the material of the vertecor midline osteotome 3. 0, pn 3765 confirmed that the tip of the device is made from medical grade 316 stainless steel. Similar to pedicle screws, commonly used as permanent implants in fusion spine surgery. Review of ifu 1311, rev. Al, warning note #7 states: do not use this product in dense bone including traumatic fractures, device damage resulting in pt injury may occur.
Patient Sequence No: 1, Text Type: N, H10
[74839194]
One unit was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause is attributed to excessive force applied during use. A review of the complaint database was performed and no similar complaints were found for this lot. A review of the device history record was performed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00001 |
| MDR Report Key | 4417714 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-01-28 |
| 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 | ROBERT FOUNDS |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4083219999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLLINE OSTEOTOME 3.0 |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-01-09 |
| Returned To Mfg | 2017-03-13 |
| Model Number | 3353 |
| Catalog Number | 3353 |
| Lot Number | 141124A02 |
| ID Number | NA |
| Device Expiration Date | 2016-09-01 |
| 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 | 2015-01-09 |