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

(b)(4).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 (b)(4) 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 10 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
• MDR Report Key: 7081532
• MDR Text Key: 93682248
• Report Number: 8030965-2017-50286
• 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

• 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
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/02/2018
• 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