MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; DISPENSER, CEMENT

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Pma / 510k: this report is for unknown needles - unknown lot; unknown part; unknown udi.Device is an instrument and is not implanted/explanted.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.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.

Event Description

It was reported that a surgery was planned: stenoplasty with vertebral body stent system (vbs) and vertecem v + took place on (b)(6) 2017, but cement has "tied-off" faster than usual, the cement needles could not be removed.The trocars and cement needles were cut off as close as possible to the pedicles and a portion remained in the patient.It was noted that moving the "cement seals" in the vertebral body.Decision of the surgeon, perform a long initial stretching and spinal fusion with another manufacturer's product for stabilization of the situs, thoracic 10-11 and lumbar 1-2, since the stent-cement application was no longer considered stable.It was reported the surgeon noted the odor of the monomer remained in the operating room longer than usual.This complaint involves two (2) devices.This complaint is for the unknown needles.This is report 2 of 2 for (b)(4).

• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7227675
• MDR Text Key: 98577231
• Report Number: 8030965-2018-50699
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR