MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: SPINE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 (b)(6) reports an event as follows: it was reported that on the unknown date, the cervical spine locking plate - variable angle (cslp-va) was first bent and implanted due to vertebral body fracture and spinal cord injury.However, the intraoperative x-ray inspection did not show a good fit of the plate (it was too long).After that, the screws were released, and the plate was replaced by a shorter plate.During the plate change, dislocation of the ring occurred unnoticed during screw removal.The surgeon cites the cause of the loosening of the metal ring as having introduced the screws into the plate at a much too large angle (not as described in surgery technique) due to the bechterew anatomy of the spine (extreme curvature).Procedure outcome and patient status are unknown.Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown).This report is for an unknown spine plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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

It was further reported that during the procedure the plate was bent because of the spine anatomy.The bending was performed with the correct instruments.The implantation and removal of the plate (50mm plate) occurred on (b)(6) 2019 as it was too long.This is the plate with the lost ring.Thus, surgeon removed cslp 4/4,35, 6 hole, 50mm length plate and then on the same date implanted cslp 4/4,35, 6 hole plate, 43mm length plate.This report is for one (1) unknown cslp 4/4,35, 6 hole, 50mm length plate.

• Brand Name: UNK - PLATES: SPINE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8887966
• MDR Text Key: 154130772
• Report Number: 8030965-2019-67149
• Device Sequence Number: 1
• Product Code: KWQ
• 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
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR