MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI CRADLE END HALF; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.126

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Canada reported the following event: it was reported that x-rays taken on a follow-up visit on an unknown date in (b)(6) 2015, showed that the veptr to veptr ii adapter had shifted.On (b)(6) 2015, the patient was scheduled for fusion surgery (using expedium devices) as part of the patient¿s existing treatment plan.Preoperative x-rays taken on an unknown date prior to the (b)(6) 2015 surgery showed that the adapter had completely dislodged from the veptr construct.The post-operative x-rays (date unknown) showed that one small piece of metal from the veptr ii implant remained in that patient.The surgeon was not concerned, as it is the surgeon¿s opinion that it does not present any risk to the patient.It was also reported that two pangea screws have lost their polyaxial ability.The screws reportedly have fused in position and the tulip portion of the screws would no longer move.The patient¿s status following the revision surgery was not provided.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by the reporter.Date of event is unknown.Date of implant is unknown.The subject device has been received and is currently in the evaluation process.A device history record review has also been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that: the veptr device is designed to mechanically stabilize and distract the thorax to correct three dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed with thoracic insufficiency syndrome.The veptr devices are attached perpendicular to the patient¿s natural ribs, or to the lumbar vertebra or ilium.The complaint description stated that a titanium veptr to veptr ii adapter had dislodged from a construct.The whole construct was returned, including one cradle end half (part number 497.126).Part 497.126 is a cradle end half that attaches to the superior or inferior cradle to encircle the superior or inferior rib.The drawing associated with the part (497_126 rev f) was reviewed.The drawing calls out the appropriate dimensions, material and finishing processes for a successful design.The veptr cradle end half, 497.126 / lot # 5283161, was returned intact.Instrumentation marks were observed on the part, which are consistent with damages that occur during removal of the implants.No design related issues were identified.There were no specific complaint allegations regarding the cradle end half.Furthermore, visual evaluation of the part did not reveal any abnormalities.A review of the design and clinical risk management document was therefore not performed.The complaint is unconfirmed.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.

Manufacturer Narrative

Device history records was conducted.The report indicates that the: manufacturing date 08dec2006.Part 497.126- lot # 5283161 and rm lot # 4957094 did not contain any ncrs or any anomalies.(b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: TI CRADLE END HALF
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4871093
• MDR Text Key: 5860243
• Report Number: 2530088-2015-10498
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.126
• Device Lot Number: 5283161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2015; 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1