FDA Adverse Event
Injury
Summary report: N
2.4MM TI CORTEX SCREW SELF-TAPPING 6MM
MDR report key: 2772060
·
Received September 28, 2012
Report
- Report Number
- 1719045-2012-00991
- Event Type
- Injury
- Date Received
- September 28, 2012
- Report Date
- August 31, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- MQN
- PMA / PMN Number
- K981275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Additional Manufacturer Narrative · 1
(B)(4): PLACEHOLDER.
Description of Event or Problem · 1
PT WAS IMPLANTED WITH TWO (2) 2.4MM TI COMPRESSION TENSION AND PLATES AND TWELVE (12) SCREWS ON (B)(6) 2012. POSTOPERATIVELY, THE PT EXPERIENCED PAIN AND DRAINAGE. ON 08/31/2012, THE PT WAS RETURNED TO SURGERY FOR REMOVAL OF ALL HARDWARE. NO NEW HARDWARE WAS IMPLANTED AS IT WAS NOTED THAT THE FRACTURE WAS HEALED. THIS REPORT IS #4 OF 14 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM | 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM | MQN | SYNTHES MONUMENT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention | PLATES| SCREWS |