MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2007-08-31 for BIO MINI-REVO SUTURE ANCHOR, PRELOADED C6170H manufactured by Conmed Linvatec.
[681008]
It was reported that during a bankart lesion repair, after insertion of the implant the suture came out with the applicator. There was no report of injury or surgical delay with this event.
Patient Sequence No: 1, Text Type: D, B5
[7811844]
Investigation findings: to date, the investigation is still in process. A follow up report will be filed upon completion of the product evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00631 |
| MDR Report Key | 906175 |
| Report Source | 01,06,07 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-09 |
| Date of Event | 2007-08-08 |
| Date Mfgr Received | 2007-08-09 |
| Device Manufacturer Date | 2007-03-31 |
| Date Added to Maude | 2007-10-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO MINI-REVO SUTURE ANCHOR, PRELOADED |
| Generic Name | SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2007-08-31 |
| Returned To Mfg | 2007-08-28 |
| Model Number | NA |
| Catalog Number | C6170H |
| Lot Number | BBD03373 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887569 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-31 |