MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-06-02 for JET-X 71051041 manufactured by Smith & Nephew, Inc., Othopaedic Division.
[400179]
Revision surgery was required when the device fracture 3-4 weeks after the initial surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2005-00227 |
| MDR Report Key | 610024 |
| Report Source | 07 |
| Date Received | 2005-06-02 |
| Date of Report | 2005-06-02 |
| Date Mfgr Received | 2005-05-31 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-06-06 |
| 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 ANDY HARDISON, SPECIALIST |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995922 |
| Manufacturer G1 | SMITH & NEPHEW INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JET-X |
| Generic Name | SHORT CENTRAL BODY |
| Product Code | JHW |
| Date Received | 2005-06-02 |
| Returned To Mfg | 2005-05-31 |
| Model Number | NA |
| Catalog Number | 71051041 |
| Lot Number | 04KM17500 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 599832 |
| Manufacturer | SMITH & NEPHEW, INC., OTHOPAEDIC DIVISION |
| Manufacturer Address | 1450 E. BROOKS RD. MEMPHIS TN 38116 US |
| Baseline Brand Name | JET-X |
| Baseline Generic Name | SHORT CENTRAL BODY |
| Baseline Model No | NA |
| Baseline Catalog No | 71051041 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-06-02 |