MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for VERSA-TRAC LUMBAR RETRACTOR SYSTEM S-0102 manufactured by V. Mueller/bd.
[67265437]
During procedure, doctor noticed that screw from the versatrac retractor arm was missing, instrument still functioned as needed; floor was searched and doctor examined wound to look for screw, but none was discovered; unsure whether screw was in the instrument when the case was started or not. X-ray was taken and radiologist called to room to report not seeing screw on film either.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067803 |
| MDR Report Key | 6321724 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-12-22 |
| Date Added to Maude | 2017-02-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERSA-TRAC LUMBAR RETRACTOR SYSTEM |
| Generic Name | RETRACTOR |
| Product Code | GZT |
| Date Received | 2017-02-08 |
| Model Number | S-0102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER/BD |
| Brand Name | VERSA-TRAC LUMBAR RETRACTOR SYSTEM |
| Generic Name | RETRACTOR |
| Product Code | GZT |
| Date Received | 2017-02-08 |
| Model Number | S-0440 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER/BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-08 |