MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: SPINE; PLATE,FIXATION,BONE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: han w., et al (2019) the effect of bi-cortical screw fixation for subsidence and cervical alignment in patients undergoing single-level anterior cervical discectomy and fusion, the nerve volume 5(2), pages 41-48 (korea, south) https://doi.Org/10.21129/nerve.2019.5.2.41.This study aims to assess whether bi-cortical screw fixation was more favorable in terms of subsidence and cervical alignment in patients undergoing single-level acdf.Between february 1, 2002 and march 31, 2017, a total of 133 patients with herniated cervical discs were recruited.64 cases (39 males, 25 females) comprised the mono-cortically placed screw group (group a) and 69 cases (32 males, 37 females) comprised the bi-cortically placed screw group (group b).In group a, 11 cases used an atlantis cervical plate (medtronic-sofamor danek, memphis, tn, usa), 25 cases used a vectra-translation cervical plate (depuy synthes inc., west chester, pa, usa), and 28 cases used a vectra-fixed cervical plate (depuy synthes inc.).In group b, 24 cases used an atlantis cervical plate, 30 cases used a vectra-t plate, and 15 cases used a vectra-f cervical plate.The following complications were reported as follows: in the mono-cortical screw fixation and bi-cortical screw fixation group, 38 and 22 cases had significant subsidence.The mean subsidence values were 1.094¿1.28 mm, 3.472¿1.95 mm, and 4.342¿2.22 mm in the atlantis, vectra-t, and vectra-f group, respectively.In mono-cortical fixation group, 3 patients occurs pseudoarthrosis.In bi-cortical fixation group, five patients didnt achieved complete fusion.This report is for an unknown synthes vectra-fixed cervical plate.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 11029010
• MDR Text Key: 222103035
• Report Number: 8030965-2020-09837
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• 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