MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-STER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 08.802.019S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Staphylococcus Aureus (2058); Depression (2361); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of symptom onset of postoperative infection is unknown.Product code ¿xxx¿ used in place of code ¿ovd¿, which reflects common device name ¿intervertebral fusion device w/integrated fixation, lumbar,¿ as ¿ovd¿ is too new for selection.(b)(4).It is unknown if the complainant part has been explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: february 5, 2014 - expiry date: january 1, 2024.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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 synthes (b)(4) reported an event in (b)(6) as follows: it was reported the patient developed a staphylococcus aureus infection on an unknown date following a revision surgery performed on (b)(6) 2015.Surgery was performed on (b)(6) 2015 to clean and debride the wound.The need for revision surgery is addressed and reported in related complaint ((b)(4)).The patient reports that he suffers from chronic back pain and that the successive surgeries have affected his physical, aesthetical, physiological, morale, financial and social well-being.He also reports that he has gained over eight kilos due to excessive consumption of medications and cannot work or participate in sports.This report is 2 of 2 for (b)(4).

• Brand Name: SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-STER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5374428
• MDR Text Key: 36231809
• Report Number: 9612488-2016-10033
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK072253
• 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
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 08.802.019S
• Device Lot Number: 8798745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention