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 2018-10-02 for ENDPLATE ELEVATOR 20MM WIDTH 389.550 manufactured by Oberdorf Synthes Produktions Gmbh.
[122329096]
Subject device has been received and is currently in the evaluation process. A review of the device history records 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
[122329097]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent an anterior lumbar interbody fusion (alif) at lumbar spine disc l4-s1 with synfix evolution system on (b)(6) 2018. During the procedure, when the surgeon was preparing the disc site upon the removal of the disc, the endplate elevator cobb handle appeared to rotate upon itself. There was a pin in the handle that was also visible but did not appear to be loose. The surgeon then applied pressure, until the handle was firm, but the instrument was sticking and did not move freely or spring back. A kerrison (4 mm) device was used to remove the disc material and complete the surgical procedure. There was minimal delay to the surgery. This report is for one (1) endplate elevator 20 mm width. This is report 1 of 1 for pc-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56899 |
| MDR Report Key | 7925723 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2007-07-18 |
| Date Added to Maude | 2018-10-02 |
| 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 | 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 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 | ENDPLATE ELEVATOR 20MM WIDTH |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2018-10-02 |
| Returned To Mfg | 2018-10-01 |
| Catalog Number | 389.550 |
| Lot Number | AQ31567 |
| 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 | 2018-10-02 |