MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/09/2012

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: uss/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.(b)(4).

Event Description

Device report from spain reports an event as follows: this report is being filed after the review of the following journal article: antonio jiménez martín et, al (2012), vertebral stabilization, experience with 100 patients, journal of trauma and orthopaedics vol.29(2/2), pages 9-15 (spain).Our goal is to review 100 patients who underwent surgery for vertebral arthrodesis at our center, and verify both our indications in spondylolisthesis, channel stenosis, and fractures.Likewise, our objectives are also to analyze the complications and study these patients from a clinical standpoint, before and after the procedure, in order to find fundamental differences between the v.A.S.Scale and oswestry index.A total of 100 patients with a median age of 44 years whom 55% were male and 45% female were included in the study but only 56% were treated with a uss system (ao depuy-synthes).The follow-up time was a median of 15 months, a minimum of 3, and a maximum at 108 months.The article did not specify which of the devices were being used to capture the following complications: 60.6% reported lumbar pain at 6 months.Lassègue was positive in 17.2% at 6 months.54.5% reported lumbar pain at 12 months.Lassège was positive in 10.1% at 12 months.Decrease in dorsiflexion occurred in 5% at 6 months, compared to 3% at 12 months.Decrease in dorsiflexion and plantar flexion went from 3% at 6 months to 1% at 12 months.Decrease in achilles reflex occured in 2% of patients at 6 months.Impotence occurred in 1% at 6 and 12 months.Paresis in lower limbs occurred in 4% of patients at 6 months and 3% at 12 months.Paresthesias also appeared in 7% at 6 months and in 5.10% at 12 months.Foot drop occurred in 1% at 6 and 12 months.68.0% reported postoperative pain stood out.4% bruising.14.1% re interventions.10.1% need for extraction of osteosynthesis material.2 cases infections.1% drainage entrapment.1% wound infection.2% meralgia paresthetica.1% intra-abdominal migration of bone graft.1% paresis of l5.1% paresthesia in the foot.1% the possibility of recurrence.1% in dural tear.1% post-surgical cauda equina syndrome.1% the need for icu 5.1% post-surgical fever.10.1% paralytic ileus.34.3% had moderate according to kim's scale.5.10% had poor according to kim's scale.1 case of material breakages.12.1% with detachments complications.18.2% of material complication arose.11.1% of mis-placements of screws.This is for a uss system (ao depuy-synthes).This report is for one (1) unk - constructs: uss.This report is 2 of 3 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.

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.H6: code 3191 used to capture surgical intervention and medical device removal.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.

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8890779
• MDR Text Key: 154876281
• Report Number: 8030965-2019-67189
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2019

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: 10/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention