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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient weight is unknown.Event date: unknown.This report is for one (1) unknown veptr construct.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Proximal junction kyphosis that the patient developed post-operatively.Unknown, as specific part and lot numbers for the complainant veptr construct were not provided.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.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 a patient was originally implanted with a vertical expandable prosthetic titanium rib (veptr) construct on (b)(6) 2012.During the treatment period, the patient underwent three (3) scheduled extension procedures.Thereafter, the patient developed a proximal junction kyphosis.As a result, the surgeon decided to remove the construct and revise with alternate means.On (b)(6) 2015, the patient returned to the operating room for the explant procedure.In order to limit the amount of bleeding, the surgeon decided to revise the patient on a separate date.The actual revision procedure took place on (b)(6) 2015, when the patient was treated with a fixing device method.An anterior lumbar fusion (alf) and posterior lumbar fusion (plf) were conducted on the patient from t1 to l1.This report is for one (1) unknown veptr 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 (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5464316
• MDR Text Key: 39200344
• Report Number: 2520274-2016-11349
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• 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: 12 YR