MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-04-06 for SMALL HOWMEDICA BONE PLUG 1PK 6215-5-001 manufactured by Howmedica Inc..
[7772133]
Summary of evaluation: this event was found to be an isolated incident and attributed to improper orientation of the inner package during the outer seal process.
Patient Sequence No: 1, Text Type: N, H10
[17414463]
The inner and outer package lids stuck together, and the device fell on the floor. Another device was readily available. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1998-00211 |
| MDR Report Key | 161623 |
| Report Source | 07 |
| Date Received | 1998-04-06 |
| Date of Report | 1998-04-03 |
| Date of Event | 1998-03-11 |
| Date Mfgr Received | 1998-03-18 |
| Date Added to Maude | 1998-04-10 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL HOWMEDICA BONE PLUG 1PK |
| Generic Name | IMPLANT |
| Product Code | MBS |
| Date Received | 1998-04-06 |
| Returned To Mfg | 1998-03-20 |
| Model Number | NA |
| Catalog Number | 6215-5-001 |
| Lot Number | VENTA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157366 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Baseline Brand Name | ARTISAN BONE PLUG |
| Baseline Generic Name | BONE PLUG |
| Baseline Model No | NA |
| Baseline Catalog No | 6215-5-001 |
| Baseline ID | * |
| Baseline Device Family | BONE PLUG |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951860 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-06 |