MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-07-02 for BONE ANCHORS UNK BONE ANCHOR manufactured by Depuy Mitek.
[17395736]
A patient called stating that sometime in 1998 he got his left ankle got in a grain augar, and subsequently had surgery on his injured ankle. The device is alleged to be a mitek bone anchor with panacryl suture. Since the surgery in 1998, the patient has had persistant infection and pain. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[17658151]
The product is not being returned to mitek for evaluation. The alleged device is still implanted. To date, attempts to retrieve additional information with the surgeon such as if it indeed a mitek bone anchor was implanted, and why a panacryl suture which is absorbable device would be implanted in the patient have been unsuccessful. No additional information about the event or injury such as if this was indeed a mitek device, if there was a graft used in the procedure and subsequent treatment are unavailable. If an when more information is available, mitek will file a follow-up report. No corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2009-00273 |
| MDR Report Key | 1410574 |
| Report Source | 00 |
| Date Received | 2009-07-02 |
| Date of Report | 2009-07-02 |
| Date of Event | 1998-06-26 |
| Report Date | 2009-06-26 |
| Date Mfgr Received | 2009-06-26 |
| Date Added to Maude | 2009-07-13 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RONALD GIANNANGELO |
| Manufacturer Phone | 508977 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE ANCHORS |
| Generic Name | BONE ANCHORS |
| Product Code | NOV |
| Date Received | 2009-07-02 |
| Catalog Number | UNK BONE ANCHOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-02 |