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 2020-01-10 for LCP METAPHYSPL 3.5 9HO L125 TI 423.409S manufactured by Oberdorf Synthes Produktions Gmbh.
[174622876]
510k: this report is for an unk - plate: trauma/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
[174622877]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for right proximal ulna fracture with the metaphyseal plate. During the rehabilitation, the patient reported pain, and on (b)(6), the surgeon confirmed by x-rays that the plate had been broken. On (b)(6), the patient underwent re-operation by replacing the plate with a proximal ulna plate. The bone doesn? T unite, and the patient rehabilitates now. The additional incision (3cm) was needed. The concentration of the force due to the lack of fixation was the cause of the breakage of the plate. Concomitant device/s reported: unknown screws (part# unknown, lot# unknown, quantity# unknown). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00252 |
| MDR Report Key | 9577310 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-16 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-30 |
| Date Added to Maude | 2020-01-10 |
| 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 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | LCP METAPHYSPL 3.5 9HO L125 TI |
| Generic Name | APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM |
| Product Code | LXT |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-14 |
| Catalog Number | 423.409S |
| Lot Number | 1L95976 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-10 |