MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown screw/rod construct accessories /unknown lot.Part and lot numbers 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 united kingdom reports an event as follows: this report is being filed after the review of the following journal article: evaluation of healthcare outcomes of patients implanted with the depuy synthes viper pedicle screw and rod system during posterior stabilization procedures of the thoracic, lumbar, and sacral spine: a real-world evidence external registry review, british spine registry, vol xx (xx), pages 129 (united kingdom).The aim of this retrospective study is to describe patients implanted with the viper posterior stabilization devices using a national spine registry database.Between may 1, 2012 to june 31, 2020, a total of 578 patients (298 male and 280 female) with a mean age of 59.9 years (sd 15.7) were identified with viper in the text fields of the bsr database.All patients had posterior stabilization procedures in the spine.Within the viper system family, two non-fenestrated screw systems were included in the study cohort: viper/viper 2 and viper prime.The viper prime system was identified in 5 (0.9%) patients and the viper/viper 2 system was identified in the remaining patients (n=572, 99.1%) as shown in table 10.Among the study cohort, cement augmentation was noted in 31 patients.Confidence spinal cement [depuy synthes] was identified in one patient with a trauma diagnosis, and vertecem spinal cement [depuy synthes] was identified in one patient with a tumor diagnosis.No other cement was reported by name in the database.Among the patients who had cemented procedures, five patients were also implanted with fenestrated viper screws.Specifically, viper 2 fenestrated screws [depuy synthes] were identified in two patients with degenerative disease and one patient with trauma.The database also reported that the other patient with a trauma diagnosis was implanted with the viper cortical fix fenestrated screw [depuy synthes].In the one patient with a tumor diagnosis and cemented fenestrated screws noted, the brand of the fenestrated screws used was not specified.The patients were follow-up up to two years postoperatively.The following complications were reported as follows: 1 patient had implant malposition.1 patient had radiculopathyleg pain, lower back pain.1 patient had hematoma, radiculopathy, pars fracture during mobilization.2 patients had dural tear.This report is for an unknown depuy spine screw/rod construct, unknown depuy spine mono/polyaxial screws, and unknown depuy spine cement.This is report 6 of 9 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10686789
• MDR Text Key: 216395903
• Report Number: 1526439-2020-01965
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• 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