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 2020-01-14 for PSI SD800.419 PEEK IMPLANT manufactured by Oberdorf Synthes Produktions Gmbh.
[175088496]
Pma/510k: device is not distributed in the united states but is similar to device marketed in the usa. Investigation summary. Product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot. (b)(6): dhr review completed in mez on jan 09, 2020. Part: sd800. 419. Lot: 21p0060. Manufacturing site: (b)(4). Release to warehouse date: october 16, 2019. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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
[175088497]
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a skull repair surgery, doctor noted the peek implant did not completely match the patient's skull defect, the size did not match. Some margins: there was gap with the defect skull, the surgeon needed to extract autogenous bone to supplement. Some margins: larger than the defect skull and the surgeon needed to grind down. The surgery delayed about 2 hours. The patient is stable now. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00361 |
| MDR Report Key | 9587762 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2019-10-16 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| 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 MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI SD800.419 PEEK IMPLANT |
| Generic Name | PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE |
| Product Code | GXN |
| Date Received | 2020-01-14 |
| Catalog Number | SD800.419 |
| Lot Number | 21P0060 |
| 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 | 2020-01-14 |