MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for STENOFIX IMPLANT HOLDER 03.630.525 manufactured by Synthes Hagendorf.
[87236701]
No patient involvement was reported. Implant and explant dates: device is an instrument and is not implanted / explanted. Initial reporter contact number: (b)(6). Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa. Device history records review was completed for part# 03. 630. 525, lot# 7600947. Manufacturing location: (b)(4)\, manufacturing date: jan 26, 2012. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
[87236702]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that upon receiving the loan set from distributor, (b)(4) specialist found that it was broken on the weld tip holder. No patient involvement reported. This report is for one (1) stenofix implant holder. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2017-10452 |
| MDR Report Key | 6859424 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-21 |
| Date Mfgr Received | 2017-10-04 |
| Device Manufacturer Date | 2012-01-26 |
| Date Added to Maude | 2017-09-12 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STENOFIX IMPLANT HOLDER |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2017-09-12 |
| Returned To Mfg | 2017-09-11 |
| Catalog Number | 03.630.525 |
| Lot Number | 7600947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-12 |