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 |