MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2012-12-10 for BREMER HALO CROWN WITH SKULL PINS manufactured by Depuy Synthes Spine.
[2987833]
Contact in (b)(6) reports halo crown was placed onto patient due to odontoid fracture following bicycling accident. Patient was seen every 2 weeks since to evaluate and adjust skull pins if necessary. On saturday, (b)(6), 2012, the patient woke up hearing crack and the pin on the right rear side of the halo has shifted. Emergency room visited and no problems were found although the patient had a great deal of pain. Similar event happened on sunday the 2nd but with edema noted at the site. Patient is reported to have suffered severe pain and is presently being treated with pain medication. Ct scan was taken to assess the level of healing of the original odontoid fracture. This will be used to see if the halo device can be safely removed.
Patient Sequence No: 1, Text Type: D, B5
[10334393]
It is not known when the halo crown will be removed form the patient. As reported, a ct scan was taken to assess the level of healing of the original odontoid fracture. This will be used to determine if the halo crown can be safely removed. A follow up report will be filed when/if the halo crown is returned for evaluation. (b)(4): device remains on patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2012-83364 |
| MDR Report Key | 2866537 |
| Report Source | 01,04 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-12-01 |
| Date Mfgr Received | 2012-12-03 |
| Date Added to Maude | 2012-12-10 |
| 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 SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER HALO CROWN WITH SKULL PINS |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2012-12-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2012-12-10 |