MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-03-07 for CONFIDENCE BIOPSY NDLE, 15G 9" 283901915 manufactured by Depuy Synthes Spine.
[17344889]
International affiliate reports a confidence introducer needle was placed into the vertebral body. A biopsy needle was inserted through the introducer needle and, when gently hammered into the vertebral body, the tip of the biopsy needle broke off. The broken tip was removed from the vertebral body without issue. Reports there were no adverse consequences to the patient and no resulting delay.
Patient Sequence No: 1, Text Type: D, B5
[17477580]
The device is not available for evaluation and its lot code is unknown. Without a lot number, a review of manufacturing records cannot be completed. Review of complaint trends for the past twelve months found no other complaints have been reported for this item. Without a product sample we are unable to confirm the reported issue or identify the root cause. In the absence of a product sample, lot number, or observed trend, this complaint will be closed with no further action required. If the complaint product sample becomes available, the complaint file will be re-opened and the product evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-13305 |
| MDR Report Key | 2992572 |
| Report Source | 01,05,07 |
| Date Received | 2013-03-07 |
| Date of Report | 2013-02-08 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-08 |
| Date Added to Maude | 2013-05-14 |
| 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 | 3 |
| Manufacturer Contact | BETH BECOTTE |
| Manufacturer Street | 326 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283575 |
| Manufacturer G1 | DEPUY LELOCLE |
| Manufacturer Street | RUE GIRADET 29 |
| Manufacturer City | LELOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIDENCE BIOPSY NDLE, 15G 9" |
| Generic Name | DEVICE, PERCUTANEOUS, BIOPSY |
| Product Code | MJG |
| Date Received | 2013-03-07 |
| Catalog Number | 283901915 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-07 |