MAUDE Adverse Event Report: SYNTHES SELZACH TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.161.001S

Device Problem Break (1069)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: kwp, mnh, mni (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Subject device has been received and is currently in the evaluation process.Dhr review is for sterilization procedure only manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 08.Feb.2017 expiry date: 01.Jan.2027.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.Non-sterile 04.161.001/ l246665.Manufacturing location: (b)(4), manufacturing date:19.Dec.2016.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, a procedure with the synapse system was performed in the fixed range of o-c2.During surgery, the surgeon successfully screwed the two (2) sides of c2.He bent the back plate and then placed it on the back of the head.While he fixed the rear panel with the third screw, the panel cracked with a snap.The surgeon pulled out all three screws.Using a similar product to the broken device, surgeon then set the new back plate from the original position and fixed it with three (3) screws.No broken parts were found in the body, and the operation was successfully completed with a 20 minute delay.There was no adverse effect on the patient.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity 3) this report is for one (1) occipital plate this is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was performed.The occipital-plate 4.5/5 med w/50 ti is cracked at one arm of the left mounting link.Beside the crack the plate is intact, nothing is broken off.The plate is bent in various areas and shows various marks caused from unknown source.Furthermore, the anodized color was rubbed-off in various areas.Beside the plate thickness all other complaint relevant dimensions in cracked and/or bended areas cannot be checked for dimensional accuracy of the valid manufacturing specifications.The plate thickness was measured per relevant drawing and found to be within the specification.The examination of the raw-material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with ao/as if specifications and with the international standard of ti-cp grade 2 per iso 5832-02.The lot in question was manufactured with a lot size of (b)(4) pieces in december 2016 and all were distributed.We are not aware of any quality issues associated with this article- and lot number.The plate shows marks and nicks in various areas of the plate caused from unknown instruments during pre-bending.The disappeared color and marks in the cracked area point to the fact that the plate was subjected to forcible use.Point 3 in the leaflet ¿important information¿ in relevant drawing indicates: ¿correct handling of the implant is extremely important.If the shape of the implant must be altered, the device should not be bent sharply, bent backwards, notched, or scratched.Such manipulations, in addition to all other improper handling or use, can produce surface defects and/or concentrate stress in the core of the implant.This in turn may eventually cause the product to fail.¿ no manufacturing related issue was identified and/or confirmed.This complaint was determined to be caused during a mechanical overloading situation.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 OCCIPITAL PLATE-MEDIAL 50MM WIDTH
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6866429
• MDR Text Key: 87302601
• Report Number: 3000270450-2017-10329
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• 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: 08/23/2017

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: 04.161.001S
• Device Lot Number: L298926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1