MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 5.5MM TI CANCELLOUS LOCKING SCREW 24MM THRD LENGTH; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 489.145

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Date of event: date of non-union and infection is not known.(b)(4) lot unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes europe reports an event in (b)(6) as follows: it is reported patient underwent an anterior lumbar interbody fusion (alif) and was implanted with an anterior tension band (atb) plate at l4-s1 and the synfix implants at l5-s1 on (b)(6) 2013.On unknown date it was determined patient had developed a non-union and an infection at the alif site, with two (2) sacral synfix screw had backed out of the synfix cage at l5-s1.Patient was returned to surgery on (b)(6) 2017 where all hardware was removed.Procedure went smoothly and patient outcome was reported as excellent.Swabs and tissue were sent to pathology.This report is 8 of 10 for (b)(4).

Manufacturer Narrative

A product investigation was completed: complaint is confirmed as we are able to confirm complaint description based on the received x-ray; a screw back-out could be verified from the provided x-ray.Product was not returned so no further investigation could 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.

• Brand Name: 5.5MM TI CANCELLOUS LOCKING SCREW 24MM THRD LENGTH
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7081489
• MDR Text Key: 93680391
• Report Number: 8030965-2017-50284
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819776425
• UDI-Public: (01)07611819776425(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 489.145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• 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