MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,07 report with the FDA on 2014-06-27 for TRACTION, COMPONENT, INVASIVE manufactured by Synthes Usa.
[4652699]
This report is being filed after subsequent review of the following journal article: treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series, vaidya, r. , colen, r. , vigdorchik, j. , tonnos, f. , and sethi, a. J. Orthop & trauma: surgery 2012; 26:1-8. This article objective is to present a novel internal fixation device for stabilizing unstable pelvic fractures using supra-acetabular spinal pedicle screws and a subcutaneous connecting rod (infix). There were 24 patients with an average age of 40. 3 years (range, 21-71 years) with rotational or vertically unstable pelvic fractures. It is unclear if the synthes universal spine system or click-x and the use of c-rings were associated with the complications as the article failed to identify the devices associated with the complications. In the present clinical series, all fractures healed without significant loss of reduction. There were no infections, delayed union or nonunion. Male patient ((b)(6)) required repositioning of the pedicle screw and ((b)(6)) male required readjustment of screw rod junction. Both patient tolerated the procedure well and were fairly mobile after the procedure. Two male patients died ((b)(6)) in the early postoperative period secondary to multiple injuries and multisystem organ failure. This is report 3 of 4 for complaint (b)(4). This report is for an unknown pedicle screw.
Patient Sequence No: 1, Text Type: D, B5
[11926483]
Device was used for treatment, not diagnosis. Treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series, vaidya, r. , colen, r. , vigdorchik, j. , tonnos, f. , and sethi, a. J. Orthop & trauma: surgery 2012; 26:1-8. This report is for an unknown spine (c-rings). Without a lot number the device history records review could not be completed. 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
| Report Number | 2520274-2014-12163 |
| MDR Report Key | 3899265 |
| Report Source | 01,03,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-06 |
| Date Mfgr Received | 2014-06-06 |
| Date Added to Maude | 2014-06-27 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRACTION, COMPONENT, INVASIVE |
| Product Code | JEC |
| Date Received | 2014-06-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-27 |