MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-11-21 for DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS 626 manufactured by Grace Medical, Inc..
[92727153]
A complaint was received on part number 626, dornhoffer alto total implant, for a broken head during implantation. Upon further inquiry, it was revealed that the surgeon determined that the original sizing of the implant was too long and needed to be shortened. The device was shortened without the provided implant adjuster during which, the head was broken and the shaft bent. Further investigation was taken to review three other 626, dornhoffer alto total implants of the same manufacturing lot. These devices met the specifications. The dornhoffer style ha head with windows has 10+ years of clinical history with grace medical in which no valid product complaints have been received. The physician reported that he did not believe that the device caused or contributed to the patient's condition which required surgical intervention. Additionally, the physician reported that the patient was in good condition post-op with regular post-op course (treatment with tylenol with codeine for pain).
Patient Sequence No: 1, Text Type: N, H10
[92727154]
It was reported that the device broke while being implanted. The physician reported that the device was too long and needed to be adjusted/shortened. Surgery was completed with a replacement device, but the surgery was delayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000022662-2017-00010 |
| MDR Report Key | 7050004 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2017-11-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARLYN REYNOLDS |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal | 381334104 |
| Manufacturer Phone | 9013807000 |
| Manufacturer G1 | GRACE MEDICAL, INC. |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 381334104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2017-11-21 |
| Returned To Mfg | 2017-11-01 |
| Model Number | 626 |
| Catalog Number | 626 |
| Lot Number | 56720 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL, INC. |
| Manufacturer Address | 8500 WOLF LAKE DRIVE SUITE 110 MEMPHIS TN 381334104 US 381334104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-11-21 |