MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-21 for JUPITER SURGICAL JS-DC-002 42109 manufactured by Specialized Medical Devices.
[20760095]
In 2004 at hosp, dr performed vetebroplast of levels t12 and l3 on pt using the jupiter lpsds system. Upon delivery of the pmma into t-12, the pmma was allowed to harden while remaining in contact with the distal end of the delivery cannula. The distal canula tip became affixed to the hardening pmma while still within the vertebral body. While attempting to remove the cannula from within the hardened pmma within the vertebral body the cannula was bent and then broken. The distal tip of the cannula broke off and remains encapsulated within the pmma within t12 vertebral body. The pt is fine at this time and has no adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033290 |
| MDR Report Key | 555233 |
| Date Received | 2004-09-21 |
| Date of Report | 2004-09-03 |
| Date of Event | 2004-08-25 |
| Date Added to Maude | 2004-11-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUPITER SURGICAL |
| Generic Name | CLASS 1 BONE TAMP & GRAFT |
| Product Code | FGY |
| Date Received | 2004-09-21 |
| Returned To Mfg | 2004-09-03 |
| Model Number | JS-DC-002 |
| Catalog Number | 42109 |
| Lot Number | 49020913 |
| ID Number | * |
| Device Expiration Date | 2007-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544881 |
| Manufacturer | SPECIALIZED MEDICAL DEVICES |
| Manufacturer Address | 300 RUNNING PUMP RD LANCASTER PA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-21 |