MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-04-21 for IMPLANT HOLDER 10 MM 03.630.210 manufactured by Synthes Selzach.
[11768186]
Additional narrative: the initial complaint was reviewed and found not reportable. This device is not similar to any device sold/available in the us. 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
[16915453]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an operation to implant in-space implants, two screwdrivers, an implant holder and two torque limiters did not function properly. No patient adverse consequences have been reported. The procedure was prolonged for about twenty-five minutes. This is report 3 of 5 for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[17089826]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Review of the device`s test protocol showed that there were nonconformancies: in 3 of 20 implant holders, the locking screw could only be inserted in the implant holder with light exertion of force. Also there were some visual deviations like slightly faded markings found. However, all parts were released after rework. Next to that neither the needed slight force of locking screw insertion nor the visual deviations would be complaint related as the complaint is regarding moving of the implant wings and regarding attaching the implant or the locking screw. 4 of 20 implant holders had superficial damage. Device is an instrument and is not implanted/explanted. Device is not distributed in the united states, but is similar to device marketed in the usa. 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 | 3000270450-2014-10013 |
| MDR Report Key | 3762086 |
| Report Source | 01,05,07 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-03-25 |
| Date of Event | 2014-03-22 |
| Date Mfgr Received | 2014-04-22 |
| Device Manufacturer Date | 2008-11-25 |
| Date Added to Maude | 2014-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHNACKERWEG 5 |
| Manufacturer City | SELZACH CH2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT HOLDER 10 MM |
| Generic Name | HOLDER |
| Product Code | HYA |
| Date Received | 2014-04-21 |
| Returned To Mfg | 2014-04-15 |
| Catalog Number | 03.630.210 |
| Lot Number | 8083227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES SELZACH |
| Manufacturer Address | BOHNACKERWEG 5 SELZACH CH2545 SZ CH2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-21 |