MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: SYNAPSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number UNK - MONO/POLYAXIAL SCREWS: S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown screw/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 (b)(6) 2019 the patient underwent a cervical vertebrae fusion from the 3rd to 5th cervical vertebrae due to a fracture of the 5th vertebrae.On (b)(6) 2020 the patient complained about head aches, pain in the shoulder while eating, and pain on the right side.The patient was also unable to feel cold and warm.On (b)(6) 2020 it was noted that the right rod had moved completely into the brain.The left rod had also moved towards brain but still remained in the c3 and c4 screw head.A revision operation was performed on (b)(6) 2020.The skull was opened to remove the right rod from the brain.The left rod was also removed.To remove the left rod a screw driver had to be used.A normal amount of force was used to loosen the screw and nut which weren't loose.The skull was closed with a small plate and cement.A new rod was placed into the existing screws which were tightened with nuts.The revision surgery was completed successfully.The head and shoulder pain has become less.This report is for one (1) unknown screw.This is report 5 of 8 for (b)(4).This report is linked to (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.H3, h4, h6- the complaint device was not received for investigation.The following investigation is based on the x-rays provided the x-rays were reviewed, and the complaint condition could not be confirmed as no issues were identified with the mono/polyaxial screws.Since the device was not returned, dimensional, material and drawing reviews are not applicable.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

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.H3, h4, h6- investigation summary the complaint condition, that both synapse rods are migrated, could be confirmed according to the received x-rays.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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: UNK - MONO/POLYAXIAL SCREWS: SYNAPSE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10560412
• MDR Text Key: 209826711
• Report Number: 8030965-2020-07252
• Device Sequence Number: 1
• Product Code: NKB
• 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: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - MONO/POLYAXIAL SCREWS: S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention