MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-14 for MAYFIELD 2000 RADIOLUCENT HEADREST SYSTEM A2004 manufactured by Integra Lifesciences Corporation Oh/usa.
[80409403]
Surgeon had the patient prone for a cervical decompression using the radiolucent mayfield skull clamp (a2004) with the xr2 base unit. In the middle of the procedure, the system collapsed. After removing the drape, it was determined the center screw that goes through the skull clamp to hold it to the base unit snapped in two. Patient injury was reported. Revision/medical intervention was required. There was a delay in surgery due to product problem. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2017-00213 |
| MDR Report Key | 6714159 |
| Date Received | 2017-07-14 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2017-07-20 |
| Date Added to Maude | 2017-07-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAYFIELD 2000 RADIOLUCENT HEADREST SYSTEM |
| Generic Name | RADIOLUCENT SYSTEMS |
| Product Code | HBM |
| Date Received | 2017-07-14 |
| Catalog Number | A2004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-14 |