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 2017-05-25 for SYNFRAME ANGLED ROD HOLDER 387.343 manufactured by Synthes Hagendorf.
[75963667]
Additional narrative: patient information is unknown. Product code xxx used to capture product code fqp. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). Manufacturing location: (b)(4). Manufacturing date: february 05, 2013. No non-conformance reports 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. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[75963668]
Device report from synthes europe reports an event in (b)(4) as follows: it was reported that during a primary spine surgery on (b)(6) 2017, it was not possible to insert the flex-arm inside the synframe guiding tube. Additionally it was not possible to lock the flex-arm. The surgeon had to change his procedure and the patient was not implanted with a cage. The patient may have to come back for a new intervention. The surgery was prolonged about fifteen (15) minutes but there was no patient harm. No information available about patient outcome and condition. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[114561432]
The initial complaint was reviewed and found not reportable. It was determined that there is no allegation against this device and it will be reported as concomitant. 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
| Report Number | 3003875359-2017-10252 |
| MDR Report Key | 6590382 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-25 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-07-05 |
| Device Manufacturer Date | 2013-02-05 |
| Date Added to Maude | 2017-05-25 |
| 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 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 | 3 |
| Brand Name | SYNFRAME ANGLED ROD HOLDER |
| Generic Name | LAMP, OPERATING ROOM |
| Product Code | FQP |
| Date Received | 2017-05-25 |
| Catalog Number | 387.343 |
| Lot Number | 8236588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-05-25 |