MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-12-12 for SUPPORT ROD ASSM-5/16 438A1188 manufactured by Integra Lifesciences Corporation Oh/usa.
[4174114]
(b)(4) support rod of budde halo was reported to have damage to the locking mechanism. The customer alleges this is a product fault rather than customer user error. The unit was not in contact with a patient however there was a 15 minute delay in surgery and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[11514024]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2013-00249 |
| MDR Report Key | 3624935 |
| Report Source | 01,06 |
| Date Received | 2013-12-12 |
| Date of Report | 2013-12-12 |
| Date Mfgr Received | 2013-11-14 |
| Date Added to Maude | 2014-03-26 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ROD ASSM-5/16 |
| Generic Name | RETRACTOR SYSTEM COMPONENTS |
| Product Code | GZT |
| Date Received | 2013-12-12 |
| Catalog Number | 438A1188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-12-12 |