MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-16 for SOFTWARE F/ DIAGNOSIS/TREATMEN T manufactured by Wrights Lane Synthes Usa Products Llc.
[105607731]
Device used for treatment, not diagnosis. Patient information not available for reporting. Unknown when one of the rings broke. Additional product code: ktt. This report is for an unknown maxframe/unknown lot. Part and lot number are unknown; udi number is unknown. Surgery was done on the patient approximately 5 months ago. Not explanted, part of this device is an instrument. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device history records review not available for reporting at this time. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[105607732]
Maxframe complaint: it was reported that a surgeon indicated that maxframe was placed on a patient approximately 5 months ago and the patient recently returned to the office to report that one of the rings on the frame had broken. The surgeon has reinforced the frame and will continue to monitor the patient until bone consolidation is reached. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-51718 |
| MDR Report Key | 7433132 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-16 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-10-18 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-04-16 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SOFTWARE F/ DIAGNOSIS/TREATMEN T |
| Product Code | OSN |
| Date Received | 2018-04-16 |
| Returned To Mfg | 2018-08-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-16 |