MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: CERVIOS; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervios cage/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.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: helseth, ø.Et al (2019), retrospective single-centre series of 1300 consecutive cases of outpatient cervical spine surgery: complications, hospital readmissions, and reoperations, british journal of neurosurgery, vol.33 (6), pages 613-619 (norway).The aim of this retrospective single-centre study is to assess the types and rates of complications, hospital admissions, and reoperations within one year after outpatient surgery for c-dsd.Between 1 march 2008 to 14 november 2017, a total of 1300 patients (890 male and 410 female) with a median age of 49 years (range 25-77) underwent cervical spinal decompression for c-dsd.The surgical procedures performed were anterior cervical decompression and fusion (acdf) in 1083 patients using peek cages (cervios ¿ synthes, oberdorf, switzerland, and competitor) and posterior cervical foraminotomy in 217 patients.The mean follow-up period was unknown.The following complications were reported as follows: acdf group: 5 patients were reoperated within 12 months due to inadequate decompression.1 patient was reoperated within 12 months due to recurrent disc herniation at same level and side.11 patients were reoperated within 12 months due to new-onset radiculopathy from an adjacent level or other side.P1: a (b)(6) year-old female patient, who was admitted to hospital the day of surgery and stayed within 90 days due to postoperative complications, had immediate left-arm paresis and involuntary limb movements following 1-level acdf.A cerebrovascular event was suspected, although never confirmed on mri.The patient has not fully recovered.P2: a (b)(6) year-old male patient, who was admitted to hospital the day of surgery and stayed within 90 days due to postoperative complications, had immediate left-sided hemiparesis following 1-level acdf.A cerebrovascular event was suspected, and mri revealed an infarction in the right cerebral hemisphere.The patient has not fully recovered.P3: a (b)(6) year-old male patient, who was admitted to hospital within 90 days due to postoperative complications, developed right-sided paresis of the c5- and c6-innervated muscle seven days post 2-level acdf with plating.After rehabilitation, the patient has recovered considerably and has only minor deficits one-year postoperatively.P4: a (b)(6) year-old male patient had potentially life-threatening hematoma postoperatively which was detected within the planned six-hour observation period.The complication was treated with clot removal prior to discharge and recovered without sequelae.P5: a (b)(6) year-old female patient had potentially life-threatening hematoma postoperatively which was detected within the planned six-hour observation period.The complication was treated with clot removal prior to discharge and recovered without sequelae.P6: a (b)(6) year-old male patient experienced difficulty swallowing (dysphagia) and was treated with otolaryngology.The patient has not fully recovered.P7: a (b)(6) year-old male patient experienced difficulty swallowing (dysphagia) and was treated with otolaryngology.The patient has not fully recovered.P8: a (b)(6) year-old female patient experienced difficulty swallowing (dysphagia) and was treated with otolaryngology.The patient has not fully recovered.P9: a (b)(6) year-old female patient experienced difficulty swallowing (dysphagia) and was treated with otolaryngology.The patient has not fully recovered.P10: a (b)(6) year-old female patient experienced difficulty swallowing (dysphagia) or oral thrush.It was unknown if the patient recovered.P11: a (b)(6) year-old male patient sustained hoarseness or voice problems lasting more than three months after surgery and was treated with otolaryngology.The patient had not fully recovered.P12: a (b)(6) year-old female patient sustained hoarseness or voice problems lasting more than three months after surgery; a unilateral vocal cord paresis was discovered.The patient has not fully recovered.P13: a (b)(6) year-old male patient sustained hoarseness or voice problems lasting more than three months after surgery; a unilateral vocal cord paresis was discovered.The patient has not fully recovered.P14: a (b)(6) year-old male patient suffered a dural tear with csf leakage.This small dural defect was closed and sealed with a double layer of tachosil.The patient was discharged on the day of surgery and experienced an uneventful, complete recovery.P15: a (b)(6) year-old male patient, who was admitted to hospital within 90 days due to postoperative complications, developed numbness in several cervical dermatomes postoperatively.He was later diagnosed with a deep infection.The patient was treated with antibiotics and was reoperated.The patient has not fully recovered.This report is for an unknown synthes cervios cage.It captures the reported (b)(6) year-old female patient, who was admitted to hospital the day of surgery and stayed within 90 days due to postoperative complications, had immediate left-arm paresis and involuntary limb movements following 1-level acdf.A cerebrovascular event was suspected, although never confirmed on mri.The patient has not fully recovered.This is report 2 of 10 for (b)(4).Additional devices are reported under related complaint (b)(4).

• Brand Name: UNK - CAGE/SPACERS: CERVIOS
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11720361
• MDR Text Key: 262896764
• Report Number: 8030965-2021-03230
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR