MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-07-17 for PEEK CORKSCREW FT W/ NEEDLES, 4.5MM AR-1927PNF-45 manufactured by Arthrex, Inc..
[879597]
It was reported that the pt presented a reaction post operatively. Cultures performed were negative. The surgeon performed an irrigation and debridement and drained the pus out. It is unk exactly how long post operatively did the reaction occur. No further pt info is available and no add'l adverse consequences have been reported from this event. This is the first of two similar events reported by the same surgeon and medical facility. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8017156]
Device history record review revealed nothing relevant to this event. The condition reported could be related to an adverse pt reaction to any of the materials implanted. Product dfu warns of a possible allergic reaction to the implant materials. Pt sensitivity must always be considered prior to implantation. This is the first of two events reported by the same surgeon. The cause of the complainant's event could not be determined from the info available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00135 |
| MDR Report Key | 1078384 |
| Report Source | 05,06,07 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-06-24 |
| Date of Event | 2008-06-01 |
| Date Mfgr Received | 2008-06-24 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-07-25 |
| 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 | IVETTE GALMEZ, ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BLVD. |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEEK CORKSCREW FT W/ NEEDLES, 4.5MM |
| Generic Name | SUTURE ANCHOR DEVICE |
| Product Code | KGS |
| Date Received | 2008-07-17 |
| Model Number | NA |
| Catalog Number | AR-1927PNF-45 |
| Lot Number | 132440 |
| ID Number | NA |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1046936 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-17 |