MAUDE Adverse Event Report: SYNTHES SELZACH; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 495.009VS

Device Problem Crack (1135)

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

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient id, dob & weight not provided by reporter.Event date: unknown when device cracked.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.Not explanted.Unknown if device is/not expected to be returned for manufacturer review/investigation.(b)(6).Device history records was conducted.The report indicates that the: part 495.009vs / lot 9733145, please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4); supplier: (b)(4), manufacturing date: 19 november 2015, expiry date: 01 november 2025, 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.Non-sterile 495.009v / 9717841 was manufactured in (b)(4), part number 495.009v, lot# 9717841, manufacturing location: (b)(4), manufacturing date: 04 november 2015, 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.Part 495.009vs / lot 9718147, please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 09 november 2015, expiry date: 01 november 2025, 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.Non-sterile 495.009v / 9701603 was manufactured in (b)(4) part number 495.009v, lot# 9701603, manufacturing location: (b)(4), manufacturing date: 28 october 2015, 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.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 surgery on (b)(6) 2016, the surgeon was unable to turn it in 90 degree and it made some strange noise.He tried to attach the cage to the implant holder again; however, it was not successful.When he checked in image, he found the cage seemed to have some crack.The surgeon decided to leave the cage in the patient's body and completed the surgery for a lumbar spinal canal stenosis (lscs).Lot number of the reported cage must be one of the followings; 9733145 or 9718147.The surgeon used two of the above cages and he was unable to specify which one had the issue.Lot number of the reported cage must be one of the followings; 9733145 or 9718147.The surgeon used two of the above cages and he was unable to specify which one had the issue.The surgery was prolonged about 5 minutes and there was no patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device is not expected to be returned to the synthes manufacturer for evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5460419
• MDR Text Key: 39022374
• Report Number: 2520274-2016-11298
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 495.009VS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR