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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report is for an unk - plates/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Product was not returned. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients who underwent anterior-only multilevel cervical 4 decompression and instrumented fusion for degenerative disease. Based on the retrospective data review of historically treated patients, the following have been identified as the reported complications: complications: 13 patients had pseudoarthrosis. 4 patients had cervical haematoma. 3 patients had c5-palsy with recovery. 1 patient had csf leakage. 1 patient had severe postoperative delirium. 1 patient had keloid scarring. 1 patient had symptomatic screw loosening with retraction. 5 patients had chronic dysphagia. 2 patients had recurrent laryngeal nerve (rln) palsy with persistent hoarseness. 3 patients had rln palsy with recovery. Reoperations: 10 patients had posterior instrumented spinal fusion (psf) for non-union with/without symptomatic adjacent segment disease (sasd). 6 patients had anterior/posterior extension of fusion for asd. 4 patients had anterior hematoma evacuation. 1 patient had re acdf procedure for nonunion. 1 patient had re acdf procedure for asd. 1 patient had repair of csf-leak. 1 patient had early redecompression c4-6 for sever c5-palsy. 1 patient changed loosened anterior screw of c3. Revisions: 8 patients had early revisions (<1 month). 10 patients had late revisions (>1 month). Symptomatic adjacent segment disease: 51 patients had symptomatic adjacent segment disease-any level. 51 patients had asd at upper instrumented level (uiv). 24 patients had asd at lower instrumented level (liv). This report is for depuy spine skyline. This report is for (1) unknown plates. This report is 3 of 4 (b)(4). The complaint involves 44 devices. Due to a limit of impacted products per complaint, this complaint will be captured under 5 separate complaints as listed below: (b)(4) this complaint will include 10 devices - 5 plates and 5 screws (1st pc). (b)(4) this complaint will include 10 devices - 5 plates and 5 screws (2nd pc). (b)(4) this complaint will include 10 devices - 5 plates and 5 screws (3rd pc). (b)(4) this complaint will include 10 devices - 4 plates and 6 screws (4th pc). (b)(4) this complaint will include 4 devices - 2 plates and 2 screws (5th pc). For the overall complaint, adverse event review activity, mdv activity, and additional information request activity will be documented in (b)(4) (1st pc).
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Manufacturer (Section D)
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
chemin blanc 38
le locle
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
MDR Report Key11565870
MDR Text Key247656400
Report Number1526439-2021-00553
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/24/2021
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? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2021 Patient Sequence Number: 1