MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-29 for MARX PLATE LEFT, 4=11 HOLE 5620-051- N/ manufactured by Stryker Instruments.
[156777]
Three months post-operative to an iliac crest bone graft, the reconstruction plate broke. Revision surgery to replace was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010177-1999-00016 |
| MDR Report Key | 233959 |
| Report Source | 06 |
| Date Received | 1999-07-29 |
| Date of Report | 1999-07-01 |
| Date of Event | 1999-06-30 |
| Report Date | 1999-07-01 |
| Date Mfgr Received | 1999-07-01 |
| Date Added to Maude | 1999-08-03 |
| 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 | ROBIN ROWE ASSOCIATE |
| Manufacturer Street | 4100 E. MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 6163237700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARX PLATE LEFT, 4=11 HOLE |
| Generic Name | IMPLANT |
| Product Code | MRS |
| Date Received | 1999-07-29 |
| Returned To Mfg | 1999-07-15 |
| Model Number | 5620-051- |
| Catalog Number | N/ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 226769 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E. MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | MARX PLATE LEFT, 4=11 HOLE |
| Baseline Generic Name | IMPLANT |
| Baseline Model No | 5620-051- |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-29 |