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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problems Nerve Damage (1979); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
510 k: this report is for an unk - biomaterial - preformed: chronos: spine/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is jnj representative. 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. 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 reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 292 patients (148 males, 145 females) for zero-p implants against all other surgical cases recorded within the spine tango registry between (b)(6) 2012 and (b)(6) 2020. Final registry report outcome description: general complications: intraoperative 1 anesthesiologic. General complications- postoperative surgical before discharge 1 kidney / urinary, 1 liver / gi, 6 not documented. Surgical complications- intraoperative adverse events 1 nerve root damage, 3 dural lesion. Surgical complications- postoperative surgical before discharge 2 other hematoma, 1 radiculopathy, 1 csf leak / pseudo meningocele, 2 motor dysfunction, 1 sensory dysfunction, 2 other, 4 not documented, 1 implant malposition. Reoperations : number of reoperations at any level (27) 6 adjacent segment pathology, 3 failure to reach therapeutic goals, 1 implant failure, 1 instability, 6 neuro- compression, 2 non-union, 3 other, 1 sagittal imbalance, 15 unknown. Number of reoperations at the same level (4) 2 failure to reach therapeutic goals, 2 neuro- compression, 2 non-union, 1 other. This is for depuy synthes zero-p, pro disc c, prodisc vivo, prodisc-nova and chronos. The complaint involves 12 devices. Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4) this complaint will include 10 devices ¿ 5 unk - constructs: zero-p , and 5 unk - biomaterial - preformed: chronos: spine (1st pc). (b)(4) this complaint will include 2 devices ¿1 unk - constructs: zero-p , and 1 unk - biomaterial - preformed: chronos: spine (2nd pc). This report involves one (1) unk - biomaterial - preformed: chronos: spine. This report is 3 of 6 for (b)(4).
 
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Brand NameUNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11204791
MDR Text Key232825814
Report Number8030965-2021-00452
Device Sequence Number1
Product Code NDN
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 Other Health Care Professional
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
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 Received12/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/20/2021 Patient Sequence Number: 1
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