MAUDE Adverse Event Report: SYNTHES USA ACCESS KIT-STERILE; DISPENSER, CEMENT

Catalog Number 03.804.612S

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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 cement spilled into the spinal canal of a patient during a vertebral body stenting (vbs) and instrumentation procedure of an lwk-1 fracture on (b)(6) 2016.Due to the intra-operative issue, the procedure was prolonged by approximately ten (10) minutes, but was ultimately completed successfully.It was further noted that a revision procedure will not be required for this patient.Concomitant device(s) reported: vertebral body stent, small (part: 09.804.600s / lot: unknown / quantity: 2) and vertebral body stent inflation system (part: 03.804.413s / lot: unknown / quantity: 2).This report is 1 of 3 for com-(b)(4).

• Brand Name: ACCESS KIT-STERILE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5896732
• MDR Text Key: 52773915
• Report Number: 2520274-2016-14326
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.612S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 03.804.413S: INFLATION SYSTEM (X2)
• Patient Weight: 75