MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-02 for MANUAL SURGICAL INSTRUMENT 2200-1004 manufactured by Biomet Spine Llc.
[16851453]
During surgery, the tip of an angled curette broke off. After trying to remove the piece from the patient for 30 minutes, the surgeon decided to leave the fragment in the patient. The procedure was successfully completed, and the patient has shown no adverse effects after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2014-00009 |
| MDR Report Key | 3982948 |
| Report Source | 08 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-06-10 |
| Date Mfgr Received | 2014-06-10 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2014-08-15 |
| 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 | 0 |
| Manufacturer Contact | STEPHEN MORAY |
| Manufacturer Street | 310 INTERLOCKEN PKWY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL SURGICAL INSTRUMENT |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2014-07-02 |
| Model Number | 2200-1004 |
| Lot Number | LX-1170 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE LLC |
| Manufacturer Address | BROOMFIELD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-02 |