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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervical spine locking plate (cslp) / 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: hung-chuan pan, chun-i huang, ming-tech chen, and liang-shong lee (1999 anterior cervical stabilization with the synthes cervical spine locking plate system, chinese medical journal vol.62, no.12 pages 852-858 (taiwan).The aim of this study is to review the experience using the cslp system and to evaluate its ability to stabilize the cervical spine.Between august 1993 and april 1996, a total of 20 patients (10 males and 10 females) with the mean age of 49 years (ranges, 28-71 years) were included in the study.These patients underwent cervical spine fusion using synthes cslp (cervical spine locking plate).The mean duration of follow-up was 36 months.The following complications were reported as follows: a (b)(6) year-old female, postoperative mri showed minimal implant artifacts.A (b)(6) year-old female, postoperative mri showed minimal implant artifacts.A (b)(6) year-old female had a poor neurologic outcome at 54 months follow-up.This report is for an unknown synthes cervical spine locking plate (cslp).This is report 1 of 2 for complaint (b)(4).It captures the (b)(6) year-old female who had a poor neurologic outcome at 54 months follow-up.

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE, 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: 9130228
• MDR Text Key: 162812534
• Report Number: 8030965-2019-68790
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/27/2019
• 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
• Patient Age: 36 YR