MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-06-12 for DEPUY ACE OPEN BACK HALO RING-LARGE 1305 manufactured by Depuy Ace Medical Co..
[20524582]
When mri of cervical spine was attempted, patient described severe pain in 2 posterior pin sites of halo ring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020311-1997-00021 |
| MDR Report Key | 98733 |
| Report Source | 07 |
| Date Received | 1997-06-12 |
| Date of Report | 1997-06-06 |
| Date of Event | 1997-04-08 |
| Date Facility Aware | 1997-04-18 |
| Report Date | 1997-06-06 |
| Date Mfgr Received | 1997-04-18 |
| Date Added to Maude | 1997-06-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY ACE OPEN BACK HALO RING-LARGE |
| Generic Name | HALO RING |
| Product Code | KQZ |
| Date Received | 1997-06-12 |
| Model Number | NA |
| Catalog Number | 1305 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 97310 |
| Manufacturer | DEPUY ACE MEDICAL CO. |
| Manufacturer Address | 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US |
| Baseline Brand Name | OPEN BACK HALO RING-LARGE |
| Baseline Generic Name | HALO RING |
| Baseline Model No | NA |
| Baseline Catalog No | 1305 |
| Baseline ID | * |
| Baseline Device Family | CERVICAL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K914858 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-12 |