MAUDE Adverse Event Report: SYNTHES HAGENDORF PRODISC-L SUP-PL SIZ M 6°; PROSTHESIS INTERVERTEBRAL DISC

Catalog Number SSX520K

Device Problem Sticking (1597)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6).(b)(4).The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history review: manufacturing location: (b)(4) - manufacturing date: november 6, 2013 - expiry date: october, 1, 2023.No anomalies were detected during device history record review.No non-conformance reports (ncr) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient was originally implanted with a prodisc-l construct on an unknown date due to lumbar back pain.Sometime thereafter, the patient began reporting pain and lack of mobility.The lack of mobility, which blocked the kyphosis prosthesis, was further confirmed via dynamic views/imaging.A revision/explant procedure occurred on (b)(6)-2015.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Additional information regarding revision surgery: the device was replaced with a cage king at ldr.

Manufacturer Narrative

Product investigation evaluation: slight deformations are visible on the edges of the device due to removal.The spherical surface is still intact and a smooth sliding is still ensured.Therefore, a design related failure can be rejected.With only the given information, it is not possible to determine what led to the revision surgery.Neither a manufacturing, nor a product development related issue was identified and/or confirmed.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: PRODISC-L SUP-PL SIZ M 6°
• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5225102
• MDR Text Key: 31251828
• Report Number: 3003875359-2015-10474
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: SSX520K
• Device Lot Number: 8641734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention