MAUDE Adverse Event Report: SYNTHES USA VERTECEM II MIXING KIT-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 08.702.017S

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

Patient Problem Reaction (2414)

Event Date 12/03/2015

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the patient de-saturated shortly after a vertebroplasty in which vertecem ii was used.The oxygen saturation dropped shortly after the procedure was completed.Computerized axial tomography (ct scan) showed a small pulmonary embolus (pe), but nothing that would support the amount of desaturation that took place in the surgeon's opinion.The surgeon suspects a possible systemic reaction to the cement.Another surgery procedure for december 3, 2015 was cancelled due to the patient's reaction.The patient is now fully recovered and doing fine.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Only patient last initial known; no other patient information is known.Device was 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.

Manufacturer Narrative

Additional narrative: updated patient information provided by reporter.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: (b)(6) 2016, it is also reported patient suffered lumbar scoliosis and flat back deformity.Surgery was cancelled at the time of event.Patient underwent unplanned ct scan of the chest as a result of this event.Patient was returned to surgery on (b)(6) 2015, causing a delay of 5 days.Surgeon reports patient suffered no long term sequelae as a result of this event.No further information is available.

• Brand Name: VERTECEM II MIXING KIT-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 5324466
• MDR Text Key: 34278631
• Report Number: 2520274-2015-18084
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08.702.017S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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: 69 YR
• Patient Weight: 72