MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.This report is for an unknown veptr ii device construct.Part and lot numbers were not provided by reporter.Other: udi# is unavailable.Implant dates of veptr ii construct are (b)(6) 2014 and (b)(6) 2015 for extension.The subject device construct remains implanted in the patient as of the aware date of this report.(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient was admitted to the hospital for a postoperative infection on (b)(6) 2015.The patient presented with rubefaction of the wound site and high c-reactive protein (crp) test results.The patient had undergone a veptr ii extension surgery on (b)(6) 2015.This surgery was a planned procedure as part of treatment for the patient's progressive scoliosis with severe thoracic deformity.The patient was hospitalized from (b)(6) 2015 and received cefazolin sodium intravenous infusions to treat the infection.The patient was discharged from the hospital on (b)(6) 2015 upon recovery.Additional events related to this patient and implants are addressed and reported separately in related complaint ((b)(4)).This report is for an unknown veptr ii device construct.This report is 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5286063
• MDR Text Key: 33180243
• Report Number: 2520274-2015-17775
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• 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
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR