MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-14 for 2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM 401.156E manufactured by Wrights Lane Synthes Usa Products Llc.
[138807152]
Additional device product code: hwc, mqn, jey. Implanted in (b)(6) 2018; exact date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[138807153]
It was reported on an unknown date; the patient underwent hardware removal procedure due to infection. There two (2)titanium broad plate 6 holes, one (1)titanium large locking plate 12 holes, five (5) titanium coretx screw self-tapping with flutes 6mm, one (1) titanium emergency screw 6mm, five (5) titanium cortex screw coarse pitch self-tapping 12mm, two (2) titanium cortex screw coarse pitch self-tapping 14mm, one (1) titanium cortex screw coarse pitch self-tapping 10mm, four (4) titanium emergency screw 12mm implanted in (b)(6) 2018. One of the three plates implanted became infected, and patient wanted them to be removed. The procedure was successfully completed with four (4) hours surgical delay. Patient outcome was unknown. This complaint involves total twenty-one (21) devices. This complaint captures ten (10) devices. Due to system limitation remaining eleven (11) devices are captured in the related complaints (b)(4). This report is for one (1) 2. 0mm ti cortex screw self-tapping with flutes 6mm. This is report 6 of 10 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56961 |
| MDR Report Key | 8421126 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-14 |
| Date of Report | 2019-02-20 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-03-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM |
| Generic Name | SCREW FIXATION INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2019-03-14 |
| Model Number | 401.156E |
| Catalog Number | 401.156E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-14 |