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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD

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SYNTHES USA ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD Back to Search Results
Device Problem Packaging Problem (3007)
Patient Problem No Code Available (3191)
Event Date 04/25/2017
Event Type  Injury  
Manufacturer Narrative
Corrected data: upon receipt of the additional information on july 19, 2017 it was detected that previously reported device unknown locking cap (reported under complaint (b)(4), alert date: apr 27, 2017) is no longer associated with complaint (b)(4) and needs its own complaint. Therefore a new complaint (b)(4) has been opened to address the issue of the locking cap. 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
Concomitant reported parts: 2x click'x spondylolisth. Screw (part 499. 552 lot 8767839 and 8784689), 2x click'x spondylolisth. Screw (part 499. 551 lot 8593112 and 7942649), 2x rod (part 498. 154 lot 8708913 and 9023296), 7x click'x locking cap (part 498. 570 1x lot 8895051 and 6x lot 9569162).
 
Manufacturer Narrative
Upon receipt of the additional information on july 19, 2017 it was detected that previously reported device unknown locking cap (reported under complaint (b)(4), (b)(4), alert date: apr 28, 2017) is no longer associated with complaint (b)(4) and needs its own complaint. Therefore a new complaint (b)(4) has been opened to address the issue of the locking cap. Additional device product codes: mni, mnh, kwp, kwq this report is for one (1) unknown end cap. Part and lot numbers are unknown. Without a specific part and lot numbers, the udi is not available. Device is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6) (510k): unknown, as specific part number for end cap is not provided. Patient code is used as the package was missing an end cap which led to the surgeon putting in the screw without an end cap. The patient eventually needed a revision surgery prompted by a loosening screw. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient was a victim of spinal cord injury by firearm projectile in 2016, with l4 fracture requiring l2-l3-l5-s1 arthrodesis. During the initial surgery insufficiency of blockers in the sent box was verified (only 7, surgery with placement of 8 screws, without contamination of blockers during the surgery). As the patient was already anesthetized, the surgeon decided to leave the l5 screw to the left without a blocker. Post-operatively approx. One year the patient needed a revision surgery severe low back pain and severe deformity in the operated area. This complaint addresses the intraoperative issue of blocker (locking cap) missing during initial surgery. The postoperative issues of severe back pain, issues of s1 level screw loosening and disconnection of right l5 level screw has been reported under the linked complaint (b)(4). This report is for one (1) unknown end cap. This is report 1 of 1 for complaint (b)(4).
 
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Type of DeviceORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6757010
MDR Text Key225040541
Report Number2520274-2017-12020
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/01/2017 Patient Sequence Number: 1
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