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.
[4202796]
Multiple reports involving the same product, with the same issue from the same facility. Ref (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 and there was no injury, however there was a 15 minute delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
[11514028]
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 | 3004608878-2013-00251 |
| MDR Report Key | 3624952 |
| 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 |