MAUDE Adverse Event Report: SYNTHES USA PE INLAY W/TANTALUM MARKER MEDIUM-10MM-STERILE; PROTHESIS, INTERVERTEBRAL DISC

Catalog Number SSX626

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Unknown if device is expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient declares that the beginning of (b)(6), the prosthesis went down one level and broke to vertebrae.Patient is now in a rehabilitation center since patient had to undergo 3 operations.(b)(6) 2015: explantation (removal) of the prosthesis and implantation of a cage and arthrodesis.(b)(6): at 11 month post-operative dislocation of the polyethylene inlay with isthmic rupture.Reoperation on the (b)(6) 2015 removal of the prodisc l implant via a left retroperitoneal approach, correction of the spondylolisthesis l5-s1 and arthrodesis with synfix, on (b)(6) 2015 percutaneous posterior stabilization l5-s1 with viper.On (b)(6) 2015 removal of the pedicle screws on the right due to the apparition of a paresis and hypoesthesia in the right foot in the territory of l5 (no hematoma but suspicion of a radicular conflict with the pedicle screws).The patient presents actually a paresis and hypoesthesia with an ongoing recuperation, radicular pain.A neurological investigations and emg is planned at one month.According to the surgeon still too early to judge about any sequelae (need to wait 12 months).Patient re-operated on (b)(6) 2015 for a dislocation of the prosthesis, 1 year after implantation, replaced by an alif cage.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

(b)(6).The lot number provided aa2879, was not found to be a valid lot number.Without a lot number the device history records review could not be completed.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 reported that on (b)(6) 2015, four non-synthes screws were added in the vertebrae.On (b)(6) 2015, two screws were removed because they were touching the nerve.On (b)(6) 2015, the patient had a re-operation for the dislocation of the prosthesis.This was one year after the initial implantation.The prosthesis was replaced by an alif cage.The provided x-rays and ct scans were reviewed by the manufacture and it was noted: prodisc l is implanted at l5/s1 level.The inlay has migrated anteriorly.L5 posterior bony element fracture can be noticed, but it's difficult to determine if that occurred prior to the prodisc l surgery or not without comparing pre-op image.

Manufacturer Narrative

Udi number: (b)(4).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

During review of the complaint file it was noted that there does not appear to be any proof of breakage of the implant itself; it seems like it is a migration or subsidence failure mode.

• Brand Name: PE INLAY W/TANTALUM MARKER MEDIUM-10MM-STERILE
• Type of Device: PROTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5150319
• MDR Text Key: 28297066
• Report Number: 2520274-2015-16639
• Device Sequence Number: 1
• Product Code: MJO
• 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: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSX626
• Device Lot Number: AA2879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR