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

Catalog Number 04.632.000S

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient age & weight not provided.Additional product codes: mnh mni kwq kwp.(b)(4).Date returned to manufacturer.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: this dhr review is for sterilization procedure only: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 05 november 2015 expiry date: 01 october 2025.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 history records was conducted.The report indicates that the: non-sterile 04.632.000 / 9896127 was manufactured in us, (b)(4), manufacturing location: (b)(4) manufacturing date: 04-sep-2015 part #: 04.632.000, lot#: 9896127 (non-sterile) - ti matrix locking cap.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.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 on an event in (b)(6) as follows: it was reported that the patient had a surgery in segment l5/s1 on (b)(6) 2016 with matrix 5.5.Because of her obesity and therefore poor fluoroscopy there had to be a revision surgery on (b)(6) 2016.For locking cap removal the surgeon used the technique as in the technique guide described (torque limiting handle, screwdriver shaft 03.632.401 and counter torque 03.632.049).In position l5 left the locking cap did not loosen even after turning the t-handle more than ten times clock- and counterclockwise.Therefore the surgeon decided to use the operace set.The operace set has no torque limiter, so the tip of the screwdriver broke and remained in the locking cap.So they had to leave the left side as it had been implanted.The tip of the operace screwdriver remained in the patient.When the surgeon tried to loosen the locking cap in l5 right he again used the original surgery technique.Although he used the torque limiting handle the tip of the screwdriver 03.632.401 broke, but could be removed.Besides that he then could remove the two screws on the right side and place new ones correctly.The patient is fine and does not complain about pain.Surgeon is satisfied with the outcome of this revision.The surgery was prolonged.This complaint involves 1 parts.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A return date of october 2025 was reported in error ¿ the device was not returned.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

This is report 1 of 4 for (b)(4).

• Brand Name: TI MATRIX LOCKING CAP
• Type of Device: ORTHOSIS, SPINAL PEDICLE, FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5585157
• MDR Text Key: 42915078
• Report Number: 3000270450-2016-10098
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.000S
• Device Lot Number: 9714656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 98