MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: PLATE/SCREWS; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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

Patient Problems Calcium Deposits/Calcification (1758); Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979)

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.Event occurred at an unknown date.This report is for an unknown device/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

Device report from china reports an event as follows: this report is being filed after the review of the following journal article: chen, x.Et al.(xxxx), anterior cervical ossified posterior longitudinal ligament en bloc resection for the treatment of cervical ossification ofposterior longitudinal ligament (china).The objective of this study is to evaluate theclinical efficacy and safety of anterior cervical ossified posterior longitudinal ligament en bloc resection (ace), and analyze the advantages of ace compared to the traditionally anterior cervical surgery.From april 2010 to march 2017, a total of 96 patients who suffered from cervical ossification of the posterior longitudinal ligament (opll.) underwent anterior cervical surgery using an appropriate model of anterior cervical locking titanium plate (slim-loe, depuy company, usa).There were 57 males and 39 females, aged 32-69 years, average 54.6=8.7 years.The standard follow-up time points were 3, 6, 12, and 24 months after surgery, followed by follow-up every 1 to 2 years.The following complications were reported as follows: 6 cases of dural ossification were found.2 cases of 90 patients with dural ossification were accompanied by severe dural ossification adhesion, and cerebrospinal fluid leakage occurred during the separation.3 cases had postop cnerve root palsy.1 case was found on the first day after surgery, and 2 cases were found on the second day after surgery.Strength, accompanied by shoulder soreness.On the first day, 10 mg of torasemide was intravenously injected and methylprednisolone was intravenously infused for 3 days at doses of 120 mg, 80 mg, and 40 ng, respectively.After discharge, the muscle strength of deltoid muscle and biceps brachii muscle returned to the preoperative level in 2 patients at 3 months after operation, and the soreness completely subsided; the muscle strength of 1 patient returned to the preoperative level at 8 months after operation, and the soreness basically subsided at 1 year after operation.1 case of horner syndrome occurred immediately after operation, manifested as upper facial ptosis of the left eye, and the treatment measures were the same as cs nerve root paralysis, which returned to normal during follow-up at 6 months after operation.2 cases of moderate dysphagia with hoarseness on the second postoperative day, and a cool liquid or semi-liquid diet.One patient was followed up for 1 year after operation, and the symptoms were basically relieved; the other patient still complained of mild throat foreign body sensation 2 years after operation.5 patients had mild throat foreign body sensation immediately after surgery, and the patients were asked to avoid hard diet.The symptoms were relieved 1 to 5 months after surgery, with an average of (3.13 ¿ 1.49) months.This report is for unk - constructs: plate/screws.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14986039
• MDR Text Key: 295687661
• Report Number: 1526439-2022-01009
• Device Sequence Number: 1
• Product Code: KWQ
• 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: 07/12/2022
• 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: 06/13/2022
• 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): Other