MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-11-17 for CHISEL 10MM PDL322 manufactured by Synthes Monument.
[1671350]
During a prodisc-l procedure at l5-s1, the surgeon was using the chisel 10mm and it split the vertebral body and pushed a small piece of the posterior cortex back in towards the spinal cord. Surgeon placed the prodisc-l and completed the procedure. The following day, the patient was returned to the operating room for removal of the small piece of bone. Surgeon indicated he felt the event was due to a dull chisel.
Patient Sequence No: 1, Text Type: D, B5
[8803611]
Additional information has been requested. Subject device is an instrument and is not implanted. Investigation could not be concluded, no conclusion could be drawn. No device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number. Manufacture date could not be determined without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2010-00339 |
| MDR Report Key | 1909906 |
| Report Source | 05,07 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-10-29 |
| Date of Event | 2010-10-28 |
| Date Mfgr Received | 2010-10-29 |
| Date Added to Maude | 2010-12-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL 10MM |
| Generic Name | CHISEL |
| Product Code | EML |
| Date Received | 2010-11-17 |
| Model Number | NA |
| Catalog Number | PDL322 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-17 |