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 2011-03-16 for BREMER 3D CROWN SYSTEM 292301001 manufactured by Depuy Spine, Inc..
[20412936]
On (b)(6) 2010, the 3d crown was fixed to the pt. In (b)(6) 2011, it was found through mri that the anterior pins penetrated the inner table of skull. Cerebrospinal fluid leaked from the right forehead bone. Cramp occurred and the level of consciousness was decreased. Also, pneumocephalus occurred together. Then pt's condition was monitored. The pt's previous disease was rheumatism. The doctor requested to know why 8 pound torque is appropriate for the fixation. As an adverse outcome was reported, an mdr is filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[20577221]
Skull pin penetration is a known possible adverse outcome. Pt had rheumatism which indicates that the pt may have compromised bone quality. At this time, the specific pt info is not known. Pin insertion should be done under fluoro to ensure proper penetration. Then the pins are re-tightened 24-48 hours after placement and then as needed. The system comes with torque limiting caps that break away at 8 in/lbs. For pts with compromised bone, the user should use the torque pin driver that comes in the package. The pin driver should also be used when re-tightening to 2-3 in/lbs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2011-00039 |
| MDR Report Key | 2023370 |
| Report Source | 01,05,07 |
| Date Received | 2011-03-16 |
| Date Mfgr Received | 2011-02-16 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-03-23 |
| 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 | ANDREW TOPOULOS |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282790 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER 3D CROWN SYSTEM |
| Generic Name | SKULL BRACE/HAX |
| Product Code | HAX |
| Date Received | 2011-03-16 |
| Model Number | NA |
| Catalog Number | 292301001 |
| Lot Number | J61007AR |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-16 |