MAUDE Adverse Event Report: SYNTHES USA 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Catalog Number 04.617.816

Device Problem Fitting Problem (2183)

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

Event Date 01/28/2015

Event Type  malfunction  

Event Description

It was reported that on an unknown date a patient had a cage, plate, and screws from a non-company implanted at c4-c5.On an unknown date, an examination revealed that the cage migrated posteriorly toward the canal.On (b)(6) 2015, the patient was returned to the operating room.The surgeon removed the existing cage, plate, and screws.He then re-instrumented at c4-c5 using the zero-p device.While impacting the zero-p into the disc space, the titanium plate attached to the peek spacer became disengaged from the peek spacer.The surgeon noted that the screws were not positioned appropriately, and the plate was not properly attached to the spacer.The plate had shifted anteriorly off the peek spacer.The surgeon removed the screws and the zero-p device, and placed a new zero-p device in the patient.Only one screw was used in the zero-p instead of four, and the surgeon then placed a competitor's plate and screws over the zero-p device at levels c4-c5.The surgery was completed with a time delay of between 14 and 30 minutes, but less than 30 minutes.The status and outcome of the patient was not provided.This report is 4 of 4 for com-(b)(4).

Manufacturer Narrative

(b)(6).Device broke intra-operatively and was not implanted or explanted.Complainant part is not available for return; part has been discarded.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.

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• 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: 4530309
• MDR Text Key: 5360616
• Report Number: 2520274-2015-11064
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.617.816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 02/20/2015
• 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 Age: 53 YR