MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-10-03 for MESHGRAFT II COMPLETE 00-2195-000-00 manufactured by Zimmer Surgical.
[3069093]
It was reported that the zimmer meshgraft ii was not meshing uniformly. Additional clinical follow up with the hospital indicated that the graft was? Partially meshed?. The initial graft was used and there was no report of additional harvest, increased surgical time, or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[10212986]
The device was returned to the manufacturer for repair and evaluation. The service record indicates that the device is 18 years old and was last returned to the manufacturer for repair on (b)(4) 1997. Inspection of the device displayed a damaged roller and cutter. Prior to repair, unit was in calibration. Damage to these components could have caused the customer? S event. The cause is most likely due to the user not maintaining the device per preventive maintenance and handling according to the instructions for use. The meshgraft ii tissue expansion system should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy. The device was serviced and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2012-00243 |
| MDR Report Key | 2776642 |
| Report Source | 05,08 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-09-06 |
| Date of Event | 2012-09-01 |
| Date Mfgr Received | 2012-09-06 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2013-01-18 |
| 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 | CINDY DICKEY |
| Manufacturer Street | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESHGRAFT II COMPLETE |
| Generic Name | MESHGRAFT II COMPLETE |
| Product Code | FXQ |
| Date Received | 2012-10-03 |
| Returned To Mfg | 2012-09-13 |
| Model Number | NA |
| Catalog Number | 00-2195-000-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-03 |