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 2018-08-20 for 3.5MM TI LOCKING SCREW SELF-TAPPING 135MM 413.035 manufactured by Oberdorf Synthes Produktions Gmbh.
[117614871]
Patient height is reported as 175cm. Patient identifier is unknown. Additional procode: ktt. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter phone number is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record review has been requested. 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
[117614872]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that (b)(6) 2018, patient underwent removal of hardware. The surgeon had cut the titanium plates in order to remove them, because of a defective screw thread on the two (2) screws. The hardware was originally implanted on (b)(6) 2018, to treat a closed fracture of the tibia's diaphysis by a reduction and an osteosynthesis with tibial and fibular plates. Surgery was completed successfully with a delay of two-hour delay. The patient's condition is stable; he is being treated with antibiotherapy for an osteoarticular infection. This report is for a 3. 5mm titanium (ti) locking screw self-tapping 35mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55820 |
| MDR Report Key | 7797865 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-20 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2018-01-17 |
| Date Added to Maude | 2018-08-20 |
| 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 | WERK GRENCHEN (CH) |
| Manufacturer Street | SOLOTHURNSTRASSE 186 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM TI LOCKING SCREW SELF-TAPPING 135MM |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-08-08 |
| Catalog Number | 413.035 |
| Lot Number | L744264 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-20 |