MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-11 for 128040 manufactured by Brooks Manufacturing Site.
[1201949]
It was reported that the k-wire bent approximately 6 weeks after the initial surgery, and that a revision surgery was required to correct.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1020279-2009-00562 |
MDR Report Key | 1379344 |
Report Source | 07 |
Date Received | 2009-05-11 |
Date of Report | 2009-05-08 |
Date of Event | 2009-05-05 |
Date Mfgr Received | 2009-05-08 |
Device Manufacturer Date | 2008-04-01 |
Date Added to Maude | 2009-05-14 |
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 | MR. JERRY HOWARD |
Manufacturer Street | 1450 BROOKS RD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal | 38116 |
Manufacturer Phone | 9013996153 |
Manufacturer G1 | BROOKS MANUFACTURING SITE |
Manufacturer Street | 1450 BROOKS ROAD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal Code | 38116 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Generic Name | K-WIRE / DZK |
Product Code | DZK |
Date Received | 2009-05-11 |
Catalog Number | 128040 |
Lot Number | 08DM10187 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BROOKS MANUFACTURING SITE |
Manufacturer Address | MEMPHIS TN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-05-11 |