MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number UNK - LAMINA/PEDICLE/PROCESS H

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown lamina/pedicle/process hooks: uss/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: fernandes, p., do brito, j.S., and monteiro, j.(2019), late implant migration with neurologic compromise as a complication of scoliosis surgery, ame case reports, vol.3 (1), pages 1-9 (portugal).This study presents a case report of a (b)(6) year old female who underwent posterior spinal fusion for a 45° low-thoracic scoliosis with hypokyphosis.A t4¿l4 posterior instrumentation was performed using a hybrid construct with a universal spinal system (uss) lateral-loading device.Local and iliac bone graft was used.Two years after the index surgery and 3 months after a car accident, the patient started to have progressive difficulty in walking, exhibiting bilateral lower-extremity weakness, increased spasticity more severe on the left side, and poor balance.Her physical examination showed a slow and spastic gait with a wide base.A ct scan was obtained when the patient became unable to walk, with global motor strength of 2/5 in the left lower extremity and 3/5 on the right.Clonus was evident and a babinski¿s was present on the left but equivocal on the right.The ct scan showed exuberant medial migration of the two upper left proximal pedicle hooks into the canal with significant spinal cord compression.The patient was admitted, and the instrumentation was promptly removed.During surgery, the surgeon realized that both pedicle hooks had migrated into the canal and were covered by a layer of bone, suggesting progressive bony remodeling during migration.The patient had an uneventful recovery with early improvement of her neurological deficits.A post-operative spine mri showed clear signs of cord edema at the level of t5.Cultures returned negative and at 6-month postoperative follow-up, the patient was able to walk without support having normal bowel and bladder function.No further procedure or surgery was undertaken.This report is for an unknown synthes uss pedicle hooks.This report is for one (1) lamina/pedicle/process hooks: uss.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9940824
• MDR Text Key: 196585056
• Report Number: 8030965-2020-02734
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - LAMINA/PEDICLE/PROCESS H
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR