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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #: this report is for unknown plate.Part#, lot# and udi # is not available.Device available for evaluation: device is not expected to be returned for manufacturer review/investigation.Pma/510k: this report is for unknown plate.Pma/510(k) number is not available.(b)(4).Device evaluated by mfr, manufacture date: product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: yahia z.Al-tamimi et.Al (2014), "fracture through fused cervical segments following trauma in a patient with klippel¿feil syndrome." british journal of neurosurgery, vol.28(3), pages 408-410 (united kingdom).This study presents a case study of a (b)(6) male presented to a non-spinal hospital following a high-impact road traffic accident.The patient underwent c4/c5 anterior cervical decompression and fusion with the competitor's cage and synthes locking compression plate (lcp).A depuy spine fixation system was used to single-stage procedure due to a large anterior gap between the endplates with a dural tear and profuse leaking of cerebrospinal fluid (csf).The following complications were reported as follows: gross distortion of the anatomy was noted posteriorly with a gap between the lateral masses on the left, a dural tear and significant csf leak.Post-operatively, a flicker of movement was noted in both shoulders and legs.The patient developed (b)(6) in an occipital pressure sore which was treated with vancomycin.Required temporary lumbar csf drainage to treat a persistent csf leak from the wound.This report is for unknown locking compression plate this is report 1 of 2 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8582233
• MDR Text Key: 144136893
• Report Number: 8030965-2019-63499
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• 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
• Date Manufacturer Received: 04/09/2019
• 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: 24 YR