MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-04-18 for BIOSTOP G CEM RESTER 16MM 546316000 manufactured by Depuy Orthopaedics, Inc..
[445255]
Pt was revised due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2006-01197 |
| MDR Report Key | 702334 |
| Report Source | 05,08 |
| Date Received | 2006-04-18 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-04-10 |
| Date Facility Aware | 2006-04-10 |
| Report Date | 2006-04-10 |
| Date Mfgr Received | 2006-04-10 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-04-25 |
| 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 | GINNY STAMBERGER, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G CEM RESTER 16MM |
| Generic Name | CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2006-04-18 |
| Model Number | NA |
| Catalog Number | 546316000 |
| Lot Number | 03K1201 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 691462 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | BIOSTOP G CEMENT RESTRICTOR 16MM |
| Baseline Generic Name | CEMENT RESTRICTOR |
| Baseline Model No | NA |
| Baseline Catalog No | 546316000 |
| Baseline ID | NA |
| Baseline Device Family | BIO STOP G |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K943727 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-18 |