MAUDE Adverse Event Report: SYNTHES USA 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Catalog Number 04.617.814

Device Problem Break (1069)

Patient Problem Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported from patient that she was implanted with synthes zero-p hardware (large format lordotic graft 8mm high) seated with four (4) screws on (b)(6) 2014.Subsequently, the patient underwent revision surgery on (b)(6) 2014 due to a screw backing out post operative.On (b)(6) 2015 the patient returned to the operating room (or) for a second revision surgery due to 2 screw breakage post-operative.This complaint is for the second revision surgery.Upon review of x-rays medical director stated: "i have reviewed attached images, however, without knowing the purpose and anatomy of most of the images, it¿s difficult to provide an appropriate interpretation.Therefore the review is only for the following three images, cervical ap, cervical lat, and cervical odontoid: a zero-p like device is implanted at c6/7 intervertebral disc space.There are two screws attach to the c6 vb and only one screw inside the c7 vb.Nothing is significant for these three screws.The plate is flush with the anterior edge of c6 and c7 vb." this report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient age and weight not provided by reporter.Unknown exactly when neck pain started or when implant malfunctioned.Lot number not reported.Without a lot number the device history record review and 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.

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• 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: 4892757
• MDR Text Key: 6832640
• Report Number: 2520274-2015-14779
• 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: Other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.617.814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention