MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-21 for RHOTON-TYPE BALL DISS 90D 71/2 TT 277277TI manufactured by Integra York Pa Inc.
[2717233]
Tip broke off in pt. After doing x-rays, they couldn't locate it and believe that tip was suctioned up. The hosp is doing their risk analysis. Rma (b)(4) was provided but instrument may not be returned. Customer is requested a replacement. On (b)(6) 2012 message left (slee). On (b)(6) 2012 customer reports the device was being used during a microdiskectomy (as in open laminectomy). The dr was probing the area, using the instrument as intended when it broke. There was not pt injury. The pt will be x-rayed when they have their return visit. The customer says the device will be returned once the fda says they can do so (slee).
Patient Sequence No: 1, Text Type: D, B5
[9930572]
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. Customer reports they are waiting for fda approval to return device to mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00050 |
| MDR Report Key | 2584474 |
| Report Source | 06 |
| Date Received | 2012-05-21 |
| Date of Report | 2012-05-21 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-09-25 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON-TYPE BALL DISS 90D 71/2 TT |
| Generic Name | NA |
| Product Code | GZX |
| Date Received | 2012-05-21 |
| Catalog Number | 277277TI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-21 |