MAUDE Adverse Event Report: SYNTHES MEZZOVICO VERTEBRAL SPACER-TR 10MMX27MM 9MM HEIGHT¿STERILE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.835S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Although requested, additional event information and clarification of the event and reported device issue have not been received as of the submission date of this report.Additional clarification has been requested regarding the implant date ((b)(6) 2015) of the ¿plate¿ and if there was allegation of complaint against the plate and if this device had been removed during the (b)(6) 2016 surgery.It is not thought at this time that this plate is the subject device as the manufacturing date of the subject device is later than the implant date reported for the plate.Furthermore, it is not known if the subject device was implanted during the reported event.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).A device history record review was performed for the subject device lot.Manufacturing location: (b)(4); supplier: (b)(4).Product manufacture date: jul 16, 2015.Product expiration date: jul 01, 2025.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016, the surgeon noted that the travios vertebral spacer had "dropped" and fragmented.According to the device report a plate had been initially implanted on (b)(6) 2015.There was no surgical delay and the patient's post-operative status was reportedly "good." additional information was not provided.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device broke during insertion; device was not implanted/explanted it was also clarified that the previously reported information about a plate from a (b)(6) 2015 procedure was incorrect.There was no plate involved in this case.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

It was clarified the surgery on (b)(6) 2016 was the initial procedure to implant a cage.The surgeon used another cage to complete the surgery when the travois cage dropped and broke.No patient harm was reported.No other medical intervention was required.The procedure was successfully completed.It was also clarified that the previously reported information about a plate from a (b)(6) 2015 procedure was incorrect.There was no plate involved in this case.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that: the involved item (art.889.835s/ lot.Aa3205) is completely produced by the external supplier (b)(4).An investigation has been performed by (b)(4) with the following outcomes: dhr review the inspection/review of the production documents did not show any deviations in the manufacturing process of (b)(4).Product inspection: the returned part was observed and evaluated under the microscope.The inspection found that an external mechanical force was applied on the involved item and this could have led to the breakage.After machining, the parts are not subjected to any further mechanical forces at (b)(4).The parts are checked several times during manufacturing process and this error would have been noticed.For these reasons the supplier came to the conclusion that this error did not occur at their site but it must have occurred due to incorrect handling during the operation.Due to the fact that the complained part was broken into several fragments, a dimensional verification on this part was not possible but the relevant dimensional features have been measured during production and no deviations have been reported.The certificate of the raw material lot#18338/ art 60010140 (peek material) was reviewed, in the certificate it is reported that the material fulfills the specification.Complaint is disposed as confirmed due to evidence that part is broken, but it's considered not valid for mezzovico because there is no evidence of issues manufacturing related.The conclusion of the investigation is that no manufacturing related issue was identified, therefore review to the specific prm and prm line is not applicable.Part is returned to customer quality as per procedure.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: VERTEBRAL SPACER-TR 10MMX27MM 9MM HEIGHT¿STERILE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5886342
• MDR Text Key: 52436948
• Report Number: 1000562954-2016-10174
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011037
• 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,Followup,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 889.835S
• Device Lot Number: AA3205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1