MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2015-03-05 for VERTECOR MIDLINE OSTEOTOME 2483 (1620) manufactured by Dfine Inc..
[5631353]
A bilateral approach was performed. The midline osteotome during the procedure became stuck in the vertebrae. The articulating tip became "kinked" on impaction with the mallet. Upon realizing this, the surgeon tried to remove the mlo. The mlo was not moving at all and extreme force was applied to try and remove of approximately 10 minutes. Eventually the introducer and the mlo came out leaving the articulating tip remaining in the patient. The midline osteotome was broken inside the vertebral body and the tip got lost between the vertebral body and the pedicle.
Patient Sequence No: 1, Text Type: D, B5
[13050043]
Device history record review: pn 2483, assembly of vertecor midline cement staging osteotome-long, lz-form, revision ab, lot tlm-1406-18 ((b)(4)). No anomalies were related to the customer complaint upon review of the dhr documentation. Tests reviewed: (b)(4), rev am - end item audit testing - mechanical testing specifications were all met for the lot. Bone cement testing - testing specifications were all met. Raw material evaluation of device: pnps 3765 revision ae, first fracture kit, blister pack, short (vm) linked o material specifications: (b)(4) revision aa midline osteotome assembly short, (b)(4) revision ab; requires the raw material (b)(4). Medical grade 316 stainless steel; similar to pedicle screws, are commonly used as permanent implants in fusion spine surgery. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00003 |
| MDR Report Key | 4599033 |
| Report Source | 05,07,08 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-10 |
| Device Manufacturer Date | 2014-10-08 |
| Date Added to Maude | 2015-04-15 |
| 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 Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 951340000 |
| Manufacturer Country | US |
| Manufacturer Postal | 951340000 |
| Manufacturer Phone | 4083219999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2015-03-05 |
| Model Number | NA |
| Catalog Number | 2483 (1620) |
| Lot Number | TLM-1406-18 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| 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 | 2015-03-05 |