MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-12 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 1620 manufactured by Dfine Inc..
[5871086]
Procedure: two level dfine stabilit procedure t8 and t9. With the pt under local sedation. The surgeon placed his trocars unipedicular at t8 and t9, the biopsy trocar was used on both levels with a successful biopsy retrieved from both. The midline osteotome was then used on both levels with great success and then the cement was injected. On viewing the ap there was only a unilateral fill so the decision was made to place trocars on the contralateral side of t8 and t9 so a more complete fill could be achieved. Once the t8 trocar was in position, it was decided to not curve the midline osteotome, but just to hit in straight to create a channel for the cement to go down and to ensure the locking delivery cannula wouldn't get any bone particles occluding the end, since it is 10mm longer than the trocar. The physician inserted the midline osteotome, at the first line at the tip of the trocar, the physician then lighted tapped it into the second line, the midline osteotome was going in straight, the physician then continued to hit the midline osteotome lightly, down to the third line however as it approached the third line on the trocar the midline osteotome seemed to fall the rest of the way in. An x-ray was taken and even through there had been not excessive force applied and no turning of the handle; the midline osteotome had curved itself through the endplate into the disc space. At this point the physician tried to retrieve the midline osteotome, but it was completely stuck, the decision was made to try and remove the midline osteotome and the trocar together in the hope that the midline osteotome would follow the path that it had gone in on. When the physician tried to do this he managed to get part of the midline osteotome out with the trocar, but it had left behind the whole tip of the midline osteotome and half of the sheath, which was still sticking out of the pt. The physician tried pliers on the part of the sheath that remained to see if he could pull it out that way. This was semi successful; it removed the remaining part of the sheath but not the tip, due to the fact the tip was in the pedicle and vertebral body the decision was mde to leave this inside the pt. No excess force was used when hitting in the midline osteotome and at no point was the grey part of the handle turned. It was suspected that the tip broke on a combination of multiple uses in sclerotic bone and passing through the endplate may have played a role in the tip becoming lodged.
Patient Sequence No: 1, Text Type: D, B5
[13479284]
Dhr review: pn 2003, stabilit first fracture kit (blister pack), revision ap, lot 150119a01 (b)(4). Pn 2002, first fracture kit, blister pack sterile, long devices, revision an, lot 141013a01 (b)(4). Pn 2980, inner tray assembly, first fracture kit, blister pack (lz form), revision ad, lot r2253a/ffk-1409-25 (b)(4). Pn 2483, assembly of vertecor midline cement staging osteotome-long, lz-form, revision ab, lot tlm-1409-22 (b)(4). No anomalies were related to the customer complaint upon review of the dhr documentation. Tests reviewed: qpi 2803, rev ao - end item audit testing - 3 test samples, testing specifications were all met. Review of ifu 1131, revision al, warning #7 do not use in dense bone; warning #9, breakage of the device may require retrieval. Evaluation of device: a review of the material specifications ms 2313 and ms 2314, the material of the vertecor midline osteotome 3. 0, pn3765 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 spin surgery. The physician confirmed that the pt is fine and that the bone was 'harder' (dense, sclerotic) than expected. It appears the combination of multiple uses in sclerotic bone, and passing through the endplate may have played a role in the unfortunate instance of it becoming lodged. Email's were sent requesting a response was from the physician and the distributor providing the requested additional info for pt info to complete section a. Attempts to collect the data were sent on may 20, 22 and 29 of 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00006 |
| MDR Report Key | 4848303 |
| Report Source | 05,07 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2015-05-12 |
| Device Manufacturer Date | 2015-01-20 |
| Date Added to Maude | 2015-06-24 |
| 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 | 0 |
| Event Location | 0 |
| 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 MIDLINE CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-06-12 |
| Model Number | NA |
| Catalog Number | 1620 |
| Lot Number | TLM-1409-22 |
| ID Number | NA |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-12 |