MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, date of birth, gender, and weight not available for reporting.Date of migration unknown.510k: this report is for an unknown synfix evolution screw (s)/unknown lot.Part and lot numbers are unknown; udi number is unknown.510k is unavailable.Implant date is unknown, devices have not been explanted.Device is not available for return.Reporter is the company representative.(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.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 was reported that during a post-operative follow up visit on an unknown date, imaging for a previous unknown spine surgery showed that synfix screws had migrated.This was on the l4/l5 implant, the caudal screws on the l5 implant.It is unknown which of the screws migrated or if all the screws had migrated.Concomitant devices: unknown spine implant (part# unknown, lot# unknown, qty unknown).This is report 2 of 4 for (b)(4).This report is for unknown synfix screw.

Manufacturer Narrative

Listed below are the part and lot numbers of the implanted synfix evolution screws; however it is unknown which of the screws listed below migrated or if all the screws had migrated.Synfix® evolution fine tip screw/25mm ¿ sterile: part # 04.835.125.02s, lot # l187158, quantity 2; synfix® evolution fine tip screw/25mm ¿ sterile: part # 04.835.125.02s, lot # l186013, quantity 4; synfix® evolution fine tip screw/30mm ¿ sterile: part # 04.835.130.02s, lot # l186034, quantity 2.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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon believes that the screw migration is related to a bone quality issue and has mentioned vertebral body subsidence.No revision surgery has been carried out, and is not planned at this stage.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7352693
• MDR Text Key: 102887156
• Report Number: 8030965-2018-52232
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 03/28/2018; 04/26/2018
• Supplement Dates FDA Received: 03/30/2018; 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention