MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-05-25 for BREMER HALO 3D CROWN 292301000 manufactured by Depuy Spine, Inc..
[1399802]
Contact in (b) (6) reported that when placing a halo crown, one of the anterior skull pins penetrated the frontal sinus by 1-2mm. According to the doctor, he did not feel tightening of the pins during surgery. After the surgery, one of the pins was replaced to prevent the pin going any further in. The patient's bone quality is poor. As an adverse event occurred an mdr is filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[8650314]
Patient was reported to have poor bone quality. Contact in (b) (6) confirmed that the surgeon was using the red torque limiting caps to tighten the skull pins. The caps are designed to break at 8 in lbs. As stated in the surgical technique / ifu provided with the device, the halo is intended to be placed on adults with good bone quality. If the product is used on patient with compromised bone, it is the responsibility of the surgeon to review the literature and ensure that the appropriate pin torque is used. Further the document states, torque limited caps are not for use on pediatric patients or for patients with compromised bone quality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2010-00075 |
| MDR Report Key | 1699456 |
| Report Source | 01,07 |
| Date Received | 2010-05-25 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-05-18 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2010-05-28 |
| 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 | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER HALO 3D CROWN |
| Generic Name | CERVICAL BRACE |
| Product Code | HAX |
| Date Received | 2010-05-25 |
| Model Number | NA |
| Catalog Number | 292301000 |
| Lot Number | 060558 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| 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 DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-25 |