MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-17 for CANCELLOUS, MINERALIZED, 0.5CC, 500-800?M RMCA505 manufactured by Biomet 3i.
[22379151]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[22379152]
The doctor indicates the inner sterile seal of the container holding bone product was broken. All outer packaging was sealed properly with no noticeable damage. The procedure was completed using a different container of bone.
Patient Sequence No: 1, Text Type: D, B5
[28955542]
Upon visual inspection, the returned jar was broken inside the product packaging. The outer packaging is in excellent condition with no observable damage from a drop or product handling. There is observable breakage on the threaded portion of the product container. The product was sent to manufacturer umtb biomedical for investigation. The umtb quality department reviewed the product and the damage on the lip of the jar was confirmed. The returned outer boxes used to package the dental product jars were visually inspected. It was noted that the boxes were intact and free of any signs of physical damage, verifying that the boxes integrity had not been compromised. Umtb performed a random inspection of dental jars and found no damage. Drop tests of the product were performed and no evidence of physical damage observed. The lot in-process inspection was reviewed and umtb product met all material and performance specifications prior to shipping. The dental product jars are 100% inspected and passed all the inspection steps required by the procedure(s). The device history record was reviewed and no nonconformity was found. The root cause of the damage could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[30870892]
Although the final evaluation has been received the product will continue to be monitored.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00742 |
| MDR Report Key | 4921688 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-09 |
| Date Mfgr Received | 2015-11-02 |
| Device Manufacturer Date | 2015-02-21 |
| Date Added to Maude | 2015-07-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DANIA PEREZ |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANCELLOUS, MINERALIZED, 0.5CC, 500-800?M |
| Generic Name | CANCELLOUS, MINERALIZED BONE |
| Product Code | NUN |
| Date Received | 2015-07-17 |
| Returned To Mfg | 2015-07-21 |
| Catalog Number | RMCA505 |
| Lot Number | 0129220197 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-17 |