MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-05-21 for LIZAROV WIRE 102101 manufactured by Smith & Nephew, Inc., Orthopaedic Div..
[188863]
It was reported that revision surgery was needed to replace broken wires on two occasions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2001-00026 |
| MDR Report Key | 333848 |
| Report Source | 05,07 |
| Date Received | 2001-05-21 |
| Date of Report | 2001-04-26 |
| Date of Event | 2001-03-14 |
| Date Mfgr Received | 2001-04-26 |
| Date Added to Maude | 2001-05-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. IVAN HARLAN, SR. ENG |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996660 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIZAROV WIRE |
| Generic Name | WIRE W/STOPPER |
| Product Code | DZK |
| Date Received | 2001-05-21 |
| Returned To Mfg | 2001-04-26 |
| Model Number | NA |
| Catalog Number | 102101 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 323212 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US |
| Baseline Brand Name | LIZAROV WIRE |
| Baseline Generic Name | WIRE W/STOPPER |
| Baseline Model No | NA |
| Baseline Catalog No | 102101 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2001-05-21 |