MAUDE Adverse Event Report: SYNTHES MEZZOVICO ZERO-P TAN CONVEX H8 TAN; INTERVERTEBRAL FUSION DEVICE

Catalog Number 04.617.198S

Device Problems Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problem Sedation (2368)

Event Date 04/23/2015

Event Type  Injury  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during insertion of the cage both parts of the cage shifted, which resulted in a malalignment in such an extend that the caudal screws could be inserted, but the cranial screws could not be inserted as they were blocked by the cage.The zero-p cage needed to be removed and replaced by a syncage c and vectra plate.The implant has the size 8, no harm was done to the patient, but the surgery was prolonged by approx 30 minutes.The surgery was completed successfully.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not reported.Explant date: not explanted.Initial reporter: facility phone number: (b)(6).Device history records was conducted.The report indicates that the manufacturing location is (b)(4) and the manufacturing date: 27 jan 2014 expiry date: 01 jan 2024.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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.

Manufacturer Narrative

Device was not implanted/explanted device is not distributed in the united states, but is similar to device marketed in the usa.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this 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.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that the zero-p implant was forwarded to the manufacturing site and checked for conformance to the specifications.All features pertinent to the complaint condition were measured as far as possible and a functional test with the pin gage was made.The features re-inspected are all according to the specifications but one plate hole presents a burr which does not allow full insertion of the pin gage.The review of the manufacturing documents revealed that the complained zero-p implant was manufactured in february 2014 in accordance with all established requirements and with no nonconformities reported.In addition we confirm that these implants are function checked per 100% before they leave the manufacturing facility.Based on these findings we conclude that the damage occurred post-manufacturing.It is likely that uneven insertion forces applied to the plate and spacer caused both parts to shift and afterwards applied mechanical force caused the deformation in the hole, which finally prevented the cranial screw to be inserted.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.

• Brand Name: ZERO-P TAN CONVEX H8 TAN
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• 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: 4779076
• MDR Text Key: 5818831
• Report Number: 1000562954-2015-10104
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2015

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 Expiration Date: 02/01/2024
• Device Catalogue Number: 04.617.198S
• Device Lot Number: 8809364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2015; 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention