MAUDE Adverse Event Report: SYNTHES USA

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/07/2012

Event Type  Injury  

Manufacturer Narrative

This device used for treatment and not diagnosis.This report is on an unknown collar, part and lot numbers are unknown.Date of event: november 7, 2012.Without a part number the 510k number cannot be provided.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.

Event Description

Journal article received: application triangular osteosynthesis for vertical unstable sacral fractures; xudong hu, fuxing pei, guanglin wang, jingguo he, qingquan kong and chongqi tu: eur spine j (2013) 22:503¿509: published online: 7 november 2012: springer-verlag berlin heidelberg 2012.Local infection was seen in two patients, and both were healed with debridement and antibiotics.22 patients with vertical unstable sacral fractures were treated with triangular osteosynthesis using the combination of universal spinal system, uss (synthes, bochum, germany) and iliosacral screw in our institution.There were 13 males and 9 females, with an average age of 30 years (range 21-48 years).Two cases of wound infection were reported, which was treated with prompt debridement, lavage, and antibiotic.The wound had healed and the internal fixation implants were not removed before bone union.(22 patients, 13 males and 9 females; mean age 30 years, range 21-48).This report is on an unknown collar, quantity is unknown.This is 4 of 4 reports for (b)(4).

• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3646250
• MDR Text Key: 22211601
• Report Number: 2520274-2014-00844
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention