MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-27 for 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM 413.035S manufactured by Oberdorf Synthes Produktions Gmbh.
[121856723]
Patient height reported as 175. 0 cms. Date of event reported as 2018, exact date patient infection began is not known. Additional product code: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[121856724]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient underwent a procedure for a closed fracture of the tibia? S diaphysis by a reduction and an osteosynthesis with tibial and fibular plates on (b)(6) 2018. Removal of the osteosynthesis material and placement of an external fixation were necessary due to scar flow. Patient was returned to surgery on (b)(6) 2018 for hardware removal. To remove the plates, surgeon cut the plates because two (2) screws had defective thread. Surgery was completed with a delay of approximately 2 hours. Patient status reported as stable. Patient is being treated with antibiotherapy for an osteoarticular infection. The defective screws are addressed in (b)(4). Patient infection is addressed in related complaints (b)(4). This report is for one (1) 3. 5mm locking screw this is report 8 of 12 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56758 |
| MDR Report Key | 7913859 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-27 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2018-09-27 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-09-27 |
| Catalog Number | 413.035S |
| Lot Number | L755679 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-27 |