MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI MATRIX LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.000

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Fitting Problem (2183)

Patient Problems Failure of Implant (1924); Sedation (2368)

Event Date 01/14/2015

Event Type  Injury  

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.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 review of the x-rays was completed: the post-operative x-rays (two views) and x-rays of implants after failure (two views) and the x-rays appear to match the complaint description of left rod slipping out of screw and right rod also appearing to have slipped compared to original position.It is difficult to comment with certainty on the status of the set screws by comparing the x-rays.

Manufacturer Narrative

Additional narrative: review of the device history records showed there were no issues during the manufacture that would contribute to this complaint condition.It is unknown when the devices loosened and slipped out of place.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that all 6 screws has loosen in spite of using the torque limiter.On the left site the rod is slip out from the last screw cranial.On the right site the rod was minimal fixed on the last screw cranial.A second surgery of 120 minutes was necessary.This report is 9 of 14 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has 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

(b)(6).Device 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

Update: it was reported that the explanted matrix system was substituted with the uss fracteur during the revision procedure.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device.The matrix locking cap (subject device) and component exhibits post production/acceptance damage that includes: the majority of the m10x1.25 thread on the locking screw has visual mechanical damage and is missing anodized coating.The sd25 face has nicks and visual damage to the form in the sd25 pocket.The saddle has visual damage to one wing.All described non-conformities/damage are not related to the manufacturing process.No indication for material or design related issue was found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX LOCKING CAP
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 4492539
• MDR Text Key: 12947075
• Report Number: 2520274-2015-10824
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.000
• Device Lot Number: 7584220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 85