MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-02-02 for TRIAL SPACER HANDLE 397.089 manufactured by Synthes Hagendorf.
[37337865]
Device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation / investigation, but has yet to be received. Device history records was conducted. The report indicates that the manufacturing site: (b)(4). Manufacturing date: 04. Apr. 2014, no ncrs were generated during production. Review of the device history record 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
[37337866]
It was reported the surgeon was performing an anterior lumbar interbody fusion at l4-s1 when the trial handle/spindle broke. While using the fra spacer system, the trial handle/spindle broke inside the trial and the trial was stuck inside the disc space. The trial was removed with kocher and surgeon had to drill the bone slightly. There was a 5 minute surgical delay and no harm to the patient. This is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2016-10067 |
| MDR Report Key | 5404280 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-01-15 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2016-02-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 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 | TRIAL SPACER HANDLE |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2016-02-02 |
| Catalog Number | 397.089 |
| Lot Number | 8918794 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-02-02 |