MAUDE Adverse Event Report: SYNTHES MEZZOVICO ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Catalog Number 04.617.135S

Device Problem Device Slipped (1584)

Patient Problem Sedation (2368)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not utilized nor was it implanted / explanted complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received (b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - manufacturing location: (b)(4).Manufacturing date: 03 july 2015.Expiry date: 01 june 2025.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during an unknown surgical procedure, the plate continuously slid off the groove which connects to the cage.The surgeon attempted to place the device twice, however a new implant needed to be opened to use in place of the malfunctioning device.The surgery was then successfully completed.There was a thirty minute surgical delay reported.The patient was reportedly in stable condition.This is report 1 of 1 for com-(b)(4).

• Brand Name: ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5517705
• MDR Text Key: 40900928
• Report Number: 1000562954-2016-10065
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: PK072981
• 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: 03/09/2016

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: 04.617.135S
• Device Lot Number: 9534010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR