MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-04-15 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[4455649]
The components of the a1040 (budde halo retractor) had issues found at incoming inspection by the distributor. There was no pt contact or pt injury. The 438b1178 (continu trac halo ring) = parts were not attached at a moving part. The 438a1024 (halo adjustment wrench) = wire was cut. The 438b1010 (halo support bracket) = did not include a spring, and the movement was not smooth. The 438a1077x (budde curved retractor) = the joint part was not attached straightly to the main body, and the axis was deviated. The 438a1011 (halo flex arm) = ring mounting area has a hole. The 438a1037 (halo pattie tray) = dented.
Patient Sequence No: 1, Text Type: D, B5
[12081543]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2014-00038 |
| MDR Report Key | 3871262 |
| Report Source | 01,08 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-14 |
| Date Mfgr Received | 2014-04-04 |
| Date Added to Maude | 2014-06-30 |
| 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 | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUDDE HALO RETRACTOR |
| Generic Name | NA |
| Product Code | GZT |
| Date Received | 2014-04-15 |
| Catalog Number | A1040 |
| Lot Number | 131 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-15 |