MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

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

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Date of event: unknown.This report is for an unknown unk - cage/plate: zero-p/unknown lot.Part and lot number are unknown; udi number is unknown.Device implanted/explanted dates are 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: 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 (b)(4).

Event Description

Device report from synthes on an event in (b)(6) as follows: this report is being filed after the review of the following literature article: bu-qing-c.Et al (2017) "comparison of clinical effects between anterior cervical zero-incision fusion system and traditional nail plate system in the treatment of cervical spondylotic myelopathy" : china j.Orthop trauma, may 2017, vol.30, no.5., pp.411-419.To compare the short-term efficacy of anterior cervical discectomy and fusion (acdf) with the traditional nail plate system and zero-p intervertebral fusion cage in the treatment of cervical spondylotic myelopathy (csm).From july 2014 to august 2015, a total of 45 csm patients were included and retrospectively analyzed, including 23 males and 22 females with an average of 53.7 years old (range 32 to 71 years).Among them, 24 cases (13 male and 11 female) were treated with anterior cervical discectomy and bone graft infusion (traditional nail plate group), and 21 cases (11 male and 10 female) were treated with zero-p intervertebral fusion after anterior cervical discectomy and spinal cord decompression (zero-p group).The patients received anteroposterior and dynamic cervical spine x-ray, cervical mri, ct and routine examinations.All patients were treated with acdf with 24 cases by traditional nail plate system fixation (group a) and 21 cases by zero-p system fixation (group b).Operation time and intraoperative bleeding were compared between the two groups.Associated complications were analyzed in two groups.The surgical segments were c3-c4, c4-c5, c5-c6 and c6-c7.The complications of dysphagia occurred in both groups after cervical surgery: in nail plate group (group a), there were 7 (29.17%, 7/24) cases of dysphagia in nail plate group, including 1 case of severe dysphagia, 3 cases of moderate dysphagia and 3 cases of mild dysphagia; in the zero-p group (group b), there were 2 (9.52%, 2/21) cases of dysphagia, including 1 case of moderate dysphagia and 1 case of mild dysphagia.This report is for an unknown zero-p intervertebral fusion cage and unknown screws.This report is 1 of 2 for (b)(4).

• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380
• MDR Report Key: 7456941
• MDR Text Key: 106437738
• Report Number: 8030965-2018-53336
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention