MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-22 for DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MM 614.757 manufactured by Globus Medical, Inc..
[3278533]
It was reported to globus by a sales rep that during a surgery, upon impaction of the broaching chisel (7mm) over a 7mm trial (14 x 16 mm, 6 degrees) the instruments were pushed too far posterior into the spinal canal. The instruments made contact with the spinal cord and resulted in what appears to be a spinal cord injury. A two level anterior cervical discectomy and fusion was performed with a cervical plate and interbody spacers to fuse the segments of the spine, c5 - c7. This procedure was performed in lieu of the originally planned surgery. Original planned surgery was going to be a 1 level cervical fusion c6 - c7, and a 1 level disc replacement c5 - c6.
Patient Sequence No: 1, Text Type: D, B5
[10622441]
A comprehensive investigation was immediately initiated on receipt of the complaint. The product was not returned for eval; however, a review was conducted of all applicable material records, manufacturing records, storage records, and distribution records according to the description of the product used with the concomitant device. All records revealed all product lots were manufactured within specifications, maintained and distributed in accordance with all federal, state and operating procedures. There was no failure of instrumentation reported. Instrument is not available for eval. There have been no previous complaints on this instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004142400-2013-00004 |
| MDR Report Key | 3076503 |
| Report Source | 07 |
| Date Received | 2013-04-22 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-04-08 |
| Date Mfgr Received | 2013-04-06 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2013-04-26 |
| 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 | DANIEL PAUL, VICE PRESIDENT |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVE |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal | 19403 |
| Manufacturer Phone | 6109301800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MM |
| Generic Name | CHISEL, BROACH, 7MM |
| Product Code | KDG |
| Date Received | 2013-04-22 |
| Model Number | 614.757 |
| Lot Number | VIL223BB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVE. AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-04-22 |