MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-06-05 for GRAFTON DBM NOT REPORTED manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[20454989]
The initial reporter called the manufacturer and reported that she had allograft bone void filler implanted in a tibial non-union fracture in 1994, and reported that? Every year or so? (for the past 20 years) she gets an "infection" (red and slightly swollen) at her incision. She? Thinks it is the (bone void filler) getting infected.? She stated:? They are baffled and can? T find any infection.? She reported that cultures and needle aspirations have been done "at one time or another" (she doesn? T recall when) and stated that cultures did not grow anything and nothing was taken at the? Aspiration? She has no reports indicating an infection (cultures have been all negative). She reports that she has not had any revision procedures. She stated that she has had a known rare bone disease (diagnosed prior to this surgery) and takes off and on antibiotics for that. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[20480060]
This medwatch form was completed using the information provided by the initial reporter. Any missing or incomplete data is the result of the information not having been provided by the initial reporter. We are therefore unable to thoroughly complete this medwatch form. No part number or lot information was provided; therefore, no review of any device history record was possible. No patient medical records were provided. Based on the limited information provided, we are unable to determine a definitive cause for this reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2014-00006 |
| MDR Report Key | 3851936 |
| Report Source | 04 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-05-06 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-06-05 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EDWARD WHEELER |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 7325422800 |
| Manufacturer G1 | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2014-06-05 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-05 |