MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2004-01-09 for CTM ACCLM ULNA W HOLES STD RT 172246989 manufactured by Depuy Orthopaedics, Inc..
[340682]
Product was labeled incorrectly. Surgery was delayed one hour and the pt has a broken bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2004-00017 |
| MDR Report Key | 505777 |
| Report Source | 05,07,08 |
| Date Received | 2004-01-09 |
| Date of Report | 2003-12-10 |
| Date of Event | 2003-12-10 |
| Date Facility Aware | 2003-12-10 |
| Report Date | 2003-12-10 |
| Date Mfgr Received | 2003-12-10 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2004-01-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727416 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CTM ACCLM ULNA W HOLES STD RT |
| Generic Name | EXTREMITIES |
| Product Code | KWJ |
| Date Received | 2004-01-09 |
| Model Number | NA |
| Catalog Number | 172246989 |
| Lot Number | X5BFB1000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 494644 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | CTM ACCLM ULNA W HOLES STD RT |
| Baseline Generic Name | CUSTOMER ELBOW |
| Baseline Model No | NA |
| Baseline Catalog No | 172246989 |
| Baseline ID | NA |
| Baseline Device Family | CUSTOM ACCLAIM ULNA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-09 |