MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-24 for GOLDENBERG TORP HA/PLAST-PORE 140917 manufactured by Gyrus Acmi, Inc..
[3496118]
It was reported to gyrusacmi that during a surgical procedure when they were placing the prosthese with a microforceps, it broke. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10847050]
At the time of this report, multiple attempts to obtain further information from the hospital have been unsuccessful, and the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2013-00006 |
| MDR Report Key | 3133243 |
| Report Source | 06 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-04-26 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-05-30 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD. |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133390 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 3901 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDENBERG TORP HA/PLAST-PORE |
| Generic Name | GOLDENBERG TORP HA/PLAST-PORE |
| Product Code | ETA |
| Date Received | 2013-05-24 |
| Model Number | 140917 |
| Catalog Number | 140917 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-24 |