MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for GARDNERER WELLS manufactured by Zimmer, Inc..
[59893804]
Patient Sequence No: 1, Text Type: N, H10
[59893805]
During a posterior cervical fusion procedure the surgeon requested gardner wells traction twine to 16 lbs. The twine is rated for much more weight. This was the first use for the twine. At the end of the procedure the twine broke and the weights fell to the operating room floor. No known harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6102534 |
| MDR Report Key | 6102534 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-09-30 |
| Report Date | 2016-10-06 |
| Date Reported to FDA | 2016-10-06 |
| Date Reported to Mfgr | 2016-10-06 |
| Date Added to Maude | 2016-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | GARDNERER WELLS |
| Generic Name | ACCESSORIES, TRACTION |
| Product Code | ILZ |
| Date Received | 2016-11-15 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 345 E. MAIN ST. WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |