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 2007-09-05 for PANALOK ANCHOR UNK manufactured by Depuy Mitek.
[718474]
Our rep is reporting that during a routine post-op follow-up examination for a shoulder repair, an x-ray was taken. It was noted that both the versalok anchor and the panalok rc used 4 weeks previously for the original repair had migrated out of the bone hole into the joint space. A revision surgery has yet to be scheduled. [this mdr is directly associated with 1221934-2007-00234, same case is also associated 1221934-2007-00230, 1221934-2007-00231, 1221934-2007-00233 & 1221934-2007-00236. This is via the fact that all of these events emanate from the same facility and the same surgeon. ]
Patient Sequence No: 1, Text Type: D, B5
[7865992]
We have just been made aware of this event and we are gathering information towards clarity. A follow-up report will detail our findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00235 |
| MDR Report Key | 907568 |
| Report Source | 05,06,07 |
| Date Received | 2007-09-05 |
| Date of Report | 2007-08-24 |
| Report Date | 2007-08-24 |
| Date Reported to Mfgr | 2007-08-24 |
| Date Mfgr Received | 2007-08-24 |
| Date Added to Maude | 2007-09-11 |
| 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 | 3 |
| Manufacturer Contact | MR ARTHUR FRIGAULT |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089773856 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANALOK ANCHOR |
| Generic Name | SOFT TISSUE FIXATION DEVICE |
| Product Code | KGS |
| Date Received | 2007-09-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 883133 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DR. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-05 |