MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI VEPTR ADAPTER; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.019

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

(b)(6) 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 1 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by the reporter.Date of event is unknown.Date of implant is unknown.Date of explant surgery was (b)(6) 2015 for reported devices except for one small metal portion of the veptr ii implant, which remains in the patient and is not considered to have been explanted.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.

Event Description

This report is 1 of 2 for com-(b)(4).

Manufacturer Narrative

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/invest summary was performed.The investigation of the complaint articles indicates that: it was discovered that a veptr to veptr ii adapter had become dislodged from the construct.Additionally two pangea screws were returned because ¿the polyaxial abilities of the screws have been fused in position, so the tulips of the screw will no longer move¿.The returned components were sent to pd spine for evaluation.The complaint condition for the adapter and polyaxial screws was able to be confirmed.Part 1: ti veptr adapter (04.641.019 lot 6085637 mfg 2/2009), pd evaluation ((b)(4)): the veptr ii titanium adapter, 04.641.019 / lot # 6085637, was returned broken and attached to the proximal extension.The distraction lock was still connected to the adapter.The two rails on the bottom that connect to the superior cradle were broken.The broken pieces were not received.The broken rails would result in dislodgement of the adapter from the superior cradle.In conclusion, part 1: ti veptr adapter (04.641.019 lot 6085637 mfg 2/2009): a root cause for the broken adapter could not be determined.The observed broken condition may occur if excessive force is applied to the construct.During the investigation no product no product design related issues were identified.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: 13feb2009.P/n 04.641.019, lot # 6085637 (and its components 04.641.019.1 lot #5882983, 04.641.001.2 lot# 5876713, 04.641.001.3 which was split in two lots: lot# 5852618 and lot# 5876714)were reviewed.In addition to components, raw material lots were reviewed: lot# 5124494, 5327304, and 5816778.An ncr was found for raw material lot #5816778.Ncr1000058 was for surface finish that exceeded the allowable surface finish requirement of ra 3.8 maximum.The ncr was given a disposition of use as is (uai) since the manufacturing process will remove the surface of the raw material, and the top level print will dictate the surface finish for each part number.This nonconformance is not relevant to the complaint condition because surface finish has no relationship to shifting of adapter ans as mentioned above, raw material surface is machined during manufacturing process and reinspected after per top level requirements.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 VEPTR ADAPTER
• 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: 4870273
• MDR Text Key: 6258983
• Report Number: 2530088-2015-10486
• 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,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.019
• Device Lot Number: 6085637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention