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 2014-12-22 for SYNCAGE TRIAL SPACER HANDLE STRAIGHT 397.034 manufactured by Synthes Usa.
[5199734]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the procedure, when putting the trial by using the handle for trial implant, straight. After insertion, the trial suddenly disengaged after certain times of impaction. The surgeon had failed to reengage manually because the locking of the trial handle is at the tip. However the locking knob was blocking by muscle and retractors as the procedure was alif. Finally, the surgeon had to remove more patient's bony structure to loosen the trapped trail. The sizer of synfix lr was cosmetically damaged as this was caused when removing the bony structure by blur. Removed bony structure , endplate of vertebra to enlarge the disc space for loosening the trial trapped. The case was prolonged 90 minutes because of this issue. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12700287]
Device was used for treatment, not diagnosis. Used (b)(4) as a product code, no code for (b)(4) in jde. Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[26262336]
Device is used for treatment, not diagnosis. Device is an instrument and not implanted/explanted. Device history records are not available as device is older than 15 years, thus surpassing the statute of limitations for retention of such documents. The first visible stock transaction is dated (b)(6) 1998. The complaint history research found that there are no apparent quality problems or failures caused by a faulty product as such. ? Alif? Referenced in initial report refers to anterior lumbar interbody fusion. 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
[26262337]
Patient is good.
Patient Sequence No: 1, Text Type: D, B5
[32780930]
Device was used for treatment, not diagnosis. (b)(6). 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 | 2520274-2014-15516 |
| MDR Report Key | 4349281 |
| Report Source | 01,05,07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-24 |
| Date Mfgr Received | 2015-03-20 |
| Date Added to Maude | 2014-12-22 |
| 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 | 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 Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCAGE TRIAL SPACER HANDLE STRAIGHT |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2014-12-22 |
| Catalog Number | 397.034 |
| Lot Number | N5007 |
| 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 USA |
| Manufacturer Address | 1302 WRIGTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-22 |