MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-07 for OSTEO-SITE BONE BIOPSY NEEDLE DBBN-11-15.0-M1M manufactured by Cook Inc.
[107655637]
(b)(4). Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[107655638]
It was reported an osteo-site bone biopsy needle broke, separation of metallic and plastic part, during the injection of cement, which caused a proximal leak of cement. This device issue caused a delay in procedure, however, a new needle was used to complete the procedure. To date, additional patient and event information have not been provided. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01383 |
| MDR Report Key | 7489847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-07 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2018-05-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEO-SITE BONE BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2018-05-07 |
| Returned To Mfg | 2018-06-01 |
| Catalog Number | DBBN-11-15.0-M1M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |