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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown zero-p locking screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not explanted 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article: y.Yang et al.(2017).Pulled-out locking screw re-screwed spontaneously in anterior cervical decompression and fusion with the zero-profile implant system, a case report, int j clin exp med 2016;9(2):4851¿4854.China.The study objective was to present a case study for a patient who had a pulled-out locking screw that had re-screwed spontaneously.The study consisted of a (b)(6) male patient presented to our hospital with neck and shoulders pain for 23 years, numbness and weak-ness of right hand for 6 months.Hypoesthesia in the right c6 and c7 roots distribution, myodynamia weakness of the right little finger was detected from physical examination.Radiologic examinations were consisted with his clinical symptoms.Anterior cervical discectomy and fusion (acdf) using the zero-p was performed at two (2) levels.Three months postoperative x-rays showed a good position of the implant.However, 6 months postoperative x-rays showed a locking screw at the segment c6/7 pulled out.Regular follow-up was recommended as he was asymptomatic and no evidence of esophageal perforation was detected.The pulled-out locking screw was found re-screwed spontaneously at the 20th month follow-up.The patient was followed again and 24 months postoperative x-rays also showed the pulled-out locking screw had re-screwed spontaneously.The patient has not reached bony fusion even 24 months after surgery, whether a revision surgery is needed remains controversial.Micro-motion at the segment existed but the patient was asymptomatic while the cervical stability was reliable.Conservative treatment method with regular follow-up was recommended after discussion with our spinal surgeons in our hospital.The patient was informed that a revision surgery was needed if symptoms occur.At present bony union is not reached but he is still asymptomatic.The following complications were reported: six months postoperative x-rays showed a locking screw at the segment c6/7 pulled out.Patient was asymptomatic and no evidence of esophageal perforation was detected.The pulled-out locking screw was found re-screwed spontaneously at the 20th month follow-up.The patient was followed again and 24 months postoperative x-rays also showed the pulled-out locking screw had re-screwed spontaneously.The patient has not reached bony fusion even 24 months after surgery.Micro-motion at the segment existed but the patient was asymptomatic while the cervical stability was reliable.Conservative treatment method with regular follow-up was recommended.The patient was informed that a revision surgery was needed if symptoms occur.At present bony union is not reached but he is still asymptomatic.This is report 1 of 1 for (b)(4).This report is for one (1) locking screw for a zero-p interbody spacer, unknown part # / lot #.A copy of the literature article is being submitted with this medwatch.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7314926
• MDR Text Key: 101565832
• Report Number: 8030965-2018-51732
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/05/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/05/2018
• 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
• Patient Age: 46 YR