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

Catalog Number 04.647.125S

Device Problem Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.(b)(6).(b)(4).The implant was not the expected size even though the package stated that it was.The surgeon implanted the original cage and then had to remove it to insert a taller cage.This resulted in bone damage due to removing the original implant because of the teeth had already imbedded itself.Device history records review was conducted.The report indicates that: dhr review for: part 04.647.125s - lot # 8352271.Manufacturing site: (b)(4).Manufacturing date: 25.Apr.2013.Expiry date: - apr 1, 2023.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A device history record review was performed for the complaint device lot.Supplier lot# dhr review showed no issues.Investigation was not possible due the missing material.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 on an event in (b)(6) as follows: it was reported that during anterior cervical discectomy fusion c5/6 surgery , the surgeon trialed a size 5mm standard lordotic cage and was informed by the rep that the trial measures 5mm, however the definitive implant measures 5.8mm to take into account the teeth on the implant as per the surgical technique.The surgeon was happy to use a 5mm implant based on this information, knowing it would be slightly higher than the trial and would be the best size for the patient.The implant was opened from it's sterile packaging and prepared for insertion.Once inserted, the surgeon found the implant to be too small in height and believed that it was not higher than the trial as expected.This then resulted in the surgeon having to open a 6mm implant instead.Even though the 5mm implant was too loose to leave insitu, it had been partially imbedded into the patient's bone when distraction was released and therefore had to be discarded.No delay or adverse event.Surgeon confirmed that the patient is recovering well.This complaint involves one part.Concomitant parts reported: 1x unknown trial spacer, part unk, lot unk + 1x distractor part unk, lot unk.This report is 1 of 1 for (b)(4).

• Brand Name: ZERO-P VA IMPLANT 5MM HEIGHT LORDOTIC-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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6135517
• MDR Text Key: 61142733
• Report Number: 1000562954-2016-10219
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 04.647.125S
• Device Lot Number: 8352271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X DISTRACTOR PART UNK, LOT UNK.; 1X UNKNOWN TRIAL SPACER, PART UNK, LOT UNK
• Patient Outcome(s): Required Intervention