MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - PLATES: SLIM-LOC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Inflammation (1932); Pain (1994); Paralysis (1997); Swelling/ Edema (4577)

Event Type  Injury  

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.Date of event: unknown event date.This report is for an unknown plates: slim-loc/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.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

This report is being filed after the review of the following journal article: yin, z.Et al (2020), value of pfirrmann degeneration score in quantifying heterotopic ossification after cervical disc replacement, chinese journal of orthopedics, vol.40 (18), pages 1245-1254 (china).The aim of this retrospective study was to investigate the value of pfirrmann degeneration score in quantifying heterotopic ossification (ho) after artificial cervical disc replacement (acdr).Between january 2009 to december 2016, a total of 120 patients (88 male and 32 females) aged 43.86 ± 8.69 years (range, 27-67 years) who underwent acdr were included.Acdr was performed using discover artificial cervical disc prosthesis (johnson & johnson, usa).For the responsibilities not meeting this standard, acdf surgery or anterior cervical corpectomy and fusion (accf) was considered as appropriate, and appropriate model of anterior cervical locking titanium plate (slim-loc, johnson & johnson, usa) was selected for fixation.100 cases of single-level replacement (9 cases of hybrid surgery), 20 cases of double-level replacement (3 cases of hybrid surgery).The mean follow-up duration was 74.08 ± 28.05 months (range, 31 ~ 125 months).The following complications were reported as follows: 1 patient developed prosthesis subsidence with displacement 1 year after surgery about 1 mm into the lower endplate of the upper vertebral body: during follow-up at 4 years after surgery, prosthesis subsidence was aggravated to 2 mm.With about 2.5 mm anterior shift of prosthesis, rom (8.47 °), 6 months after operation (15.56 °) decreased, without neurological deterioration or kyphotic deformity.The patient was asked to avoid excessive head down movement and confrontational movement, and continued follow-up observation.52 patients with pain had vas score of (6.00±1.46) points (range, 3 ~ 8 points), including 5 cases of mild pain, 27 cases of moderate pain, and 20 cases of severe pain.Postoperative vas score of (2.40±1.07) points (range, 1 ~ 4 points), including 41 cases of mild pain and 11 cases of moderate pain.38 patients (46 replacements) developed heterotopic ossification (ho), including mcafee grade i in 11, level ii 18, 17 cases of grade iii.One-level replacement, two-level placement ho occurrence with hybrid procedures 2.1 patient who received acdr (c3, 4 + c5, 6) and acdf (c4, 5 + c6, 7) had drinking water choking cough 6 hours after operation, which was considered to be superior laryngeal nerve paralysis.Methylprednisolone (120 mg, 80 mg, 40 mg) ivgtt, tesunil (20 mg) iv bolus and pulmicort respules (4 ml, bid) atomization were used 1 ~ 3 days after operation to relieve nerve edema and aseptic inflammation.After discharge, oral metronidazole neurotrophic drugs were administered for 2 weeks, and the symptoms were basically relieved 3 months after operation.3 patients had dysphagia 24 hours after operation.They were treated with methylprednisolone and atomization inhalation for 3 days, combined with oral qingfei liyan oral liquid and celebrex for 1 month.The symptoms were gradually improved after taking cold liquid or semi-liquid diet for 1 ~ 3 weeks.The dysphagia symptoms were completely relieved in 3 patients 12 ~ 15 months after operation.This is report 3 of 3 for (b)(4) this report is for an unknown depuy spine discover artificial disc replacement and unknown depuy spine slim-loc plate and screws.

• Brand Name: UNK - PLATES: SLIM-LOC
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• 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 ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15122044
• MDR Text Key: 296779614
• Report Number: 1526439-2022-01299
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 06/29/2022
• 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