MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-07-29 for HELOTOME 11MM 22-0011 manufactured by Cortek, Inc..
[258173]
Two helotome baldes were broken during surgery at the l5-s1 disc space. The broken pieces were removed from the incision and the case completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226193-2002-00006 |
| MDR Report Key | 408596 |
| Report Source | 05 |
| Date Received | 2002-07-29 |
| Date of Report | 2002-07-23 |
| Date of Event | 2001-08-14 |
| Date Mfgr Received | 2001-08-14 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2002-08-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT ZOLETTI |
| Manufacturer Street | 980 WASHINGTON ST SUITE 328 |
| Manufacturer City | DEDHAM MA 02026 |
| Manufacturer Country | US |
| Manufacturer Postal | 02026 |
| Manufacturer Phone | 7814070020 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2002-07-29 |
| Returned To Mfg | 2001-08-15 |
| Model Number | 11MM |
| Catalog Number | 22-0011 |
| Lot Number | 0140-02 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 397588 |
| Manufacturer | CORTEK, INC. |
| Manufacturer Address | 980 WASHINGTON ST., SUITE 328 DEDHAM MA 02026 US |
| Baseline Brand Name | HELOTOME |
| Baseline Generic Name | OSTEOTOME |
| Baseline Model No | 11MM |
| Baseline Catalog No | 22-0011 |
| Baseline Device Family | HELOTOME |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-07-29 |