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 2015-03-10 for INSTRUMENT, BENDING OR CONTOURING manufactured by Synthes Usa.
[5336932]
This report is being filed after the subsequent review of the following journal article: " sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study) " by fawzy et al. Journal of cardiothoracic surgery 2011, 6:63 (1-7). The aim of this retrospective study is to evaluate the initial experience of a transverse plate fixation system following wound complications associated with sternal dehiscence with or without infection following cardiac surgery. Patients were considered for plate fixation after failure of the primary standard wire closure associated with wound dehiscence. There were 40 consecutive patients [the average age was 69. 7? 9. 4 years], 31 males and 9 females. Twenty two patients (55%) were diagnosed with sternal dehiscence alone and 18 patients (45%) with associated wound discharge. All patients underwent sternal fixation using three rib plates combined with a single manubrial plate (titanium sternal fixation system? , synthes). Postoperative wound complications included: one patient (2. 5%) has post-operative bleeding. One patient (2. 5%) developed postoperative seroma after 16 days. Six patients (15%) developed post-operative superficial wound dehiscence with discharge. They all subsequently healed. Four patients (10%) developed postoperative pleural effusion that was successfully drained by thoracocentesis. One patient (2. 5%) developed post-operative pneumothorax that was drained by an intercostal chest tube. Two patients (5%) developed recurrent wound infection. One patient underwent hardware removal due to pain and one patient underwent hardware removal due to wound infection. There was one death unrelated to the sternal closure that had infective endocarditis of his prosthetic valve and died of refractory septic shock. This is report 1 of 1 for (b)(4). This report is for unknown (cmf) sternal plate fixation system. A copy of the journal article is being submitted with this medwatch.
Patient Sequence No: 1, Text Type: D, B5
[13010272]
Device was used for treatment, not diagnosis. " sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study) " by fawzy et al. Journal of cardiothoracic surgery 2011, 6:63 (1-7). This report is for an unknown (cmf) sternal plate fixation system / unknown quantity / unknown lot. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. 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 | 2520274-2015-11628 |
| MDR Report Key | 4586748 |
| Report Source | 01,03,07 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-20 |
| Date of Event | 2011-04-29 |
| Date Mfgr Received | 2015-02-20 |
| Date Added to Maude | 2015-03-10 |
| 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 |
| 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 | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-03-10 |
| 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 | 2015-03-10 |