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 2019-11-21 for PHILOS 3.5 3HO SST 241.901S manufactured by Oberdorf Synthes Produktions Gmbh.
[185300345]
Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is a synthes employee. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. (b)(4). 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
[185300346]
Device report from the (b)(6) reports an event as follows: it was reported that on an unknown date the proximal humerus internal locking system (philos) plate fractured shortly after the implantation operation on (b)(6) 2018. The patient was scheduled for an open reduction internal fixation (orif) and a new plate was inserted on (b)(6) 2018. The patient was discharged on (b)(6) 2018 for an elective left broken philos plate, left proximal humorous metalwork removal, bone grafting and revision plating. Concomitant device: unknown screws (part# unknown, lot# unknown, quantity# unknown). This report is for one (1) philos 3. 5 3ho sst. This is report 1 of 1 for pc-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-70484 |
| MDR Report Key | 9355707 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-06 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-11-21 |
| 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 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILOS 3.5 3HO SST |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2019-11-21 |
| Catalog Number | 241.901S |
| Lot Number | L903867 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-11-21 |