MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown construct/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.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: wimmer, c.And pfandlsteiner, t (2010), 6 years follow up in the treatment of severe spinal deformities, european spine journal, vol.19, page 1995 (germany).Since 2002 the treatment with veptr is established in europe.From 2005 to 2010, 48 patients (19 males and 29 females) with the average age of 7.5 were treated with an unknown synthes vertical expandable prosthetic titanium rib (veptr).In 22 cases a rib to lumbar spine hybrid was used.In 20 cases a combination from rib to rib was used and in 6 cases a rib to pelvis construct was used.The following complications were reported as follows: 1 patient showed a prolonged wound healing.1 patient had pneumonia which resolved with adequate therapy.The rib devices pull out after the lengthening procedure in 5 cases.39 out of 48 patients had 1 to 9 lengthening procedures.In 15 of the patients the second curve must be instrumented.3 cases had skin breakage and the instrumentation was removed.4 cases, a final fusion was performed this is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 2 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 8726660
• MDR Text Key: 148924991
• Report Number: 8030965-2019-65577
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: 05/28/2019
• 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