MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: song k., et al (2010), usefulness of polyetheretherketone (peek) cage with plate augmentation for anterior arthrodesis in traumatic cervical spine injury, the spine journal, volume 10, pages 50¿57 (korea, south).This retrospective study aims to evaluate the usefulness of the peek cage and plate construct in anterior interbody fusions for traumatic cervical spine injuries, by analyzing radiographic changes and clinical outcomes.From february 2002 to march 2006, a total of 58 patients (47 male and 11 female) with a mean age was 52 years (from 21 to 78 years) who underwent cage and plate construction for treatment of traumatic cervical spine injury were included in the study.Plate fixation included a cslp (cervical spine locking plate; ao north america) for anterior stabilization.Radiographic data were evaluated at the sixth week; third, sixth, ninth, 12th, and 18th month after operation; and then annually with anteroposterior, lateral, flexion/extension lateral plain x-ray for the analysis.The mean follow-up period was 38 months (from 24 to 74 months).The following complications were reported as follows: four cases did not show bony union at month 3; two in distractive-extension injury, one in distractive-flexion injury, and one in compressive-flexion injury; according to the extent of fusion, one in one-level fusion, two in two-level fusion, one in three-level fusion.1 case required an additional procedure because of delayed union.The case of the delayed union had shown nonunion and destruction of the cage, but eventually complete union was achieved after additional posterior stabilization and fusion 9 months after the operation.There was 2.17 mm of subsidence (from 0.1 mm to 4.2 mm) at the last follow-up in comparison with the one after the postoperative period (3.01 mm).Thirteen out of 58 cases (22%) showed subsidence of more than 2 mm.3 patients showed adjacent segment change.Additional surgery was performed on only 1 patient who had combined neurological distortion.2 cases occurred in two-level fusion group, and 1 case in the one-level fusion group.By injury mechanism, 2 cases with distractive-extension injury and 1 case with traumatic disc herniation showed adjacent segment change.1 case occurred above the fusion level, and 2 cases occurred below the fusion level.Clinical results of the latest followup state and injured state, five cases with grade a and one case with grade b according to the asia impairment scale were unchanged.3 cases went through additional surgery (5%): two cases of posterior fusion because of delayed union and posterior instability, respectively, and one anterior interbody fusion because of adjacent level disease.In a radiographic follow-up, one patient complained about dysphasia up to 6 weeks after the operation.Recovery from dysphasia had occurred by the 17th month of follow-up.Three patients showed dysphasia till the last follow-up.In the radiographic follow-up, two patients showed loosened screws.This report is for an unknown synthes screw.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9086546
• MDR Text Key: 163604936
• Report Number: 8030965-2019-68425
• Device Sequence Number: 1
• Product Code: HWC
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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: 08/21/2019
• 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