MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2010-07-30 for K-MEDIC BONE HOOK 9" LARGE KM48344 manufactured by Teleflex Medical Tuttlingen Gmbh.
[1569224]
Info regarding this event was received via a medwatch. Us postal date on the envelope is (b)(6) 2010. The event is described as: during a procedure, the tip of the bone hook broke off. The hip was not found. C-arm (x-ray) used to examine site. The tip was not located on the c-arm. Wet reading done and no foreign object located. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8678046]
Additional info was requested to determine if the device sample is available for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005236665-2010-00004 |
| MDR Report Key | 1785685 |
| Report Source | 00,06 |
| Date Received | 2010-07-30 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-05-24 |
| Date Mfgr Received | 2010-07-09 |
| Date Added to Maude | 2011-02-02 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-MEDIC BONE HOOK 9" LARGE |
| Generic Name | BONE HOOK |
| Product Code | KIK |
| Date Received | 2010-07-30 |
| Model Number | NA |
| Catalog Number | KM48344 |
| Lot Number | NOT PROVIDED |
| ID Number | NA |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL TUTTLINGEN GMBH |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-30 |