MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-02-07 for LARGE HOWMEDICA BONE PLUG 1PK 6215-5-021 manufactured by Howmedica Inc..
[42651]
The bone plug cross threaded on the inserter. Another plug was readily available and implanted without incident. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
[7762812]
Eval results suggest the cause of this event was attributed to the user force threading the plug onto the introducer. This resulted in improper seating of the plug on the introducer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2219689-1997-00074 |
| MDR Report Key | 68090 |
| Report Source | 07 |
| Date Received | 1997-02-07 |
| Date of Report | 1997-02-07 |
| Date of Event | 1997-01-10 |
| Date Facility Aware | 1997-01-10 |
| Report Date | 1997-02-07 |
| Date Mfgr Received | 1997-01-13 |
| Date Added to Maude | 1997-02-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE HOWMEDICA BONE PLUG 1PK |
| Generic Name | IMPLANT |
| Product Code | MBS |
| Date Received | 1997-02-07 |
| Returned To Mfg | 1997-02-02 |
| Model Number | NA |
| Catalog Number | 6215-5-021 |
| Lot Number | UOEMA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68094 |
| 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 | 6215-5-021 |
| Baseline ID | NA |
| Baseline Device Family | BONE PLUG |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| 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 | 1997-02-07 |