MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-28 for BIO-PREP BONE PREPARATION KIT 0206710000 manufactured by Stryker Instruments-kalamazoo.
[3325518]
It was reported that the sculpt left blue flakes in the patient during a procedure. The surgeon was able to suction the all of the flakes from the surgical site without patient or user injuries, and there were no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[3430887]
It was reported that the scuplt left blue flakes in the patient during a procedure. The surgeon was able to suction the all of the flakes from the surgical site without patient or user injuries, and there were no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[10607943]
A follow up report will be filed when the device is received and the quality investigatioin has been completed. Not received by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[10733270]
Upon evaluation wear was observed on the sculp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-00648 |
| MDR Report Key | 3026060 |
| Report Source | 06 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-03-04 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-04-11 |
| Device Manufacturer Date | 2012-09-20 |
| Date Added to Maude | 2013-05-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KATE LONGMAN |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE HIGHWAY #3, KM 130.2 |
| Manufacturer City | KALAMAZOO MI 49001006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 0061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-PREP BONE PREPARATION KIT |
| Generic Name | PROSTHESIS, HIP, CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2013-03-28 |
| Returned To Mfg | 2012-09-20 |
| Catalog Number | 0206710000 |
| Lot Number | 12264012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE HIGHWAY #3, KM 130.2 KALAMAZOO MI 49001006 US 49001 0061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-28 |