MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW, FIXATION, BONE

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

Patient Problems Pain (1994); Discomfort (2330); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 14-mm self tap screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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.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 reported that on september 30, 2018, the patient underwent posterior cervical exploration of wound with wound vac closure due to posterior cervical wound dehiscence with seroma.On june 10, 2013, the patient underwent anterior cervical total corpectomy, c7; anterior cervical interbody fusion, c6-c7, additional level c7-t1, with harvest of local bone graft, placement of prosthetic interverbral device, depuy bengal corpectomy cage 32mm, and placement of anterior segment instrumentation, depuy acrmed swift plus plate 36mm with 14-mm screws, and use of intraoperative fluoroscopic visualization due to ossification of posterior longitudinal ligament, c6-c7, additional level c7-t1, with extension behind the entire vertebral body of c6-c7.On january 9, 2018, the patient reports recurrent symptoms of neck pain since september 2013.He has seen multiple neurologist and orthopedic surgeon and his primary neurosurgeon in the past for the same who offered no further surgeries.With neck pain radiating to the r scapula and r arm and hand, assoc.With tingling and numbness of all fingers.Recently with l sided symptoms as well, with occ pain and tingling sensation.With difficulty fine motor movement.On august 31, 2018, the patient underwent posterolateral cervical arthrodesis, decortication of facet joints, lateral mass and transverse process c6-t1 and posterior instrumentation w/ lateral mass screws placed at c6-c7 and pedicle screws placed at t1 bilaterally due cervical pseudo arthritis, previous c7 corpectomy and cervical radiculopathy on september 11, 2018, the patient has done well since surgery w/ improvement in his "compressed feeling" in the spine, resolution of i.Paresthesias.However, his rue now has worsened pain in digits 1-3.On october 16, 2018, the patient has been doing well post operatively.He is with near complete resolution of his pre-operative symptoms except w/ persistent right first 3-digit paresthesia which has been slowly improving.On (b)(6) 2019, the patient reports he continues to do well post operatively.Pt with near complete resolution of his pre-operative symptoms w/ exception to persistent bilateral paresthesias in no specific distribution that are worse in the morning when he wakes up.On (b)(6) 2020, the patient with pmhx: cervical radiculopathy, s/p c6-t1 lami/psif on (b)(6) 2018, complicated by wound infection s/p exploration on (b)(6) 2018.On an unknown date, he had a fall when slipped on ice.He hit his shoulder and had soreness in his neck and shoulders, which has improved somewhat since.He has persistent rue radicular pain predominantly into digits 1-3 on r.He has sensation of tightness in rue.This report is for one (1) unknown 14mm self-tap screw.This report is for 4 of 6 (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: 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.Updated photo investigation 9-oct-2020: the instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could not be confirmed as the image provided shows no problem with the implant.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.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.

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10649454
• MDR Text Key: 210625212
• Report Number: 1526439-2020-01903
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Patient Sequence Number: 1
• Treatment: UNK - CAGE/SPACERS; UNKNOWN PLATES
• Patient Outcome(s): Required Intervention