MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Surgical intervention and device complication (early postoperative complications).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: studer, d.And hasler, c.(2018), are growth-friendly techniques for early onset spinal deformities also spine friendly?, swiss medical weekly vol.148(s229), page 15s (switzerland).The purpose of this study is to looked at the outcome of patients undergoing definitive posterior instrumented spinal fusion (pisf) after previous growth sparing surgical treatment for early onset scoliosis (eos).Between june 2015 and january 2018, a total of 7 patients underwent either direct or 2-staged conversion from growth sparing techniques to definitive spinal fusion.Of these patients, 6 patients were treated with unknown synthes vertical expandable prosthetic titanium ribs (veptr) with an average periods of 10.3 years.The article did not specify which of the devices were being used to capture the following complications: 3 patients had single stage implant removal and definitive pisf.4 patients underwent a staged procedure with initial hardware removal and halo-gravity traction.Average deformity correction with definitive pisf was 15° for hyperkyphosis (106°/91°) and 14° for scoliosis (74°/60°).3 of 7 patients had early postoperative complications leading to unplanned return to the operating theatre in 2 patients.This report is for an unknown synthes veptr.This report is 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8842983
• MDR Text Key: 152702841
• Report Number: 8030965-2019-66664
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention