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 2018-03-06 for REDUCTION TOOL F/SPONDYLOLISTH 03.628.104 manufactured by Oberdorf Synthes Produktions Gmbh.
[101862134]
Device was used for treatment, not diagnosis. Patient information not available for reporting. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The 510k: device is not distributed in the united states, but is similar to device marketed in the usa. Device history records review was conducted. The report indicates that the: part number: 03. 628. 104. Synthes lot number: 8324766. Release to warehouse date: 22. Jul. 2013. Manufacturing site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[101862137]
Device report from synthes on an event in (b)(6) as follows: it was reported from the loan set department, that during inspection orthokit specialist found two broken instruments on both tools there is no working thread, broken parts are not returned. No patient involvement. This complaint involves 2 parts. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-51789 |
| MDR Report Key | 7319073 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-06 |
| Date of Report | 2018-02-06 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2012-08-29 |
| Date Added to Maude | 2018-03-06 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA |
| Manufacturer Country | SZ |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDUCTION TOOL F/SPONDYLOLISTH |
| Generic Name | INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2018-03-06 |
| Returned To Mfg | 2018-03-06 |
| Catalog Number | 03.628.104 |
| Lot Number | 7946876 |
| 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 | 2018-03-06 |