MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.This report is for four (4) unknown vertebral body replacement - expandable: xrl four cases of early subsidence (which were all secondary stable) and one case of posterior implant failure with breakage of a pedicle screw with secondary cranial and caudal subsidence of the cage.Part#, lot# and udi # is not available.Date of implant/explant are unknown.Reporter contact number was not provided for reporting.This report is for four cases of early subsidence (which were all secondary stable) and one case of posterior implant failure with breakage of a pedicle screw with secondary cranial and caudal subsidence of the cage.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 subsequent review of the following literature abstract deml m.C., hoppe s., albers c.E., milavec h., benneker l.M., neukamp m.S.(2017) safety and applicability of a new, expandable, modular, anterior peek-vertebral-body-replacement-device ¿ initial clinical and radiologic results in 39 cases.Early clinical and radiological results of a new modular peek vertebral body replacement device.Eur spine j 26, p.3020.Global spine journal 7:2s, p.322s.(b)(6).Despite the differing titles and publications, both abstracts share the same information, authors and overall purpose.The authors aim was to evaluate the applicability, efficacy and safety of a new expandable, modular peek cage-system as vertebral body replacement.The study included 52 patients (31 males & 21 females) all implanted with peek-xrl-vertebral-body-replacement devices (depuy/synthes).The reasoning for implantation differed amongst the patients, 42 cases were due to trauma (15 paraplegic) and the remaining ten were due to spinal metastatic diseases.One patient died ten days post-operatively due to his underlying tumor disease.Two cases of implant malpositioning and four cases of early subsidence (which were all secondary stable) were revealed through radiologic analysis.A posterior implant failure with breakage of a pedicle screw, secondary cranial and caudal subsidence of the cage and incomplete osseous consolidation was found two years post-operatively in one patient.This report is for four (4) unknown vertebral body replacement - expandable: xrl four cases of early subsidence (which were all secondary stable) and one case of posterior implant failure with breakage of a pedicle screw with secondary cranial and caudal subsidence of the cage.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

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

A copy of the second literature article is being submitted with this medwatch.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7312965
• MDR Text Key: 101487598
• Report Number: 8030965-2018-51703
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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: 02/06/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates 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