MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SYNPOR IMPLANTS; ORTHOSIS,PEDICLE,SPINAL FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problems Visual Impairment (2138); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synpor implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: alinasab, b., qureshi, a.R., and stjärne, p.(2017), prospective study on ocular motility limitation due to orbital muscle entrapment or impingement associated with orbital wall fracture, injury, vol.48 (issue 7), pages 1408¿1416 (sweden).The aim of this prospective study is to evaluate the importance of the time from injury to surgery in relation to outcomes in ocular motility and diplopia, the time line for ocular motility and diplopia recovery and the degree of and recovery from hypesthesia.Between 2011 to 2016, a total of 21 patients (9 females and 12 males) were included in the study.Of these, 7 patients in the impingement group required reconstruction by an orbital implant (synpor, titanium mesh titanium mash covered by polyethylene).The following complications were reported as follows: 2 patients had ocular motility limitation up to the 2nd visit (3-7 weeks) after injury.However, eye movement restriction was not seen in the physicians¿ examination findings.Diplopia was reported by 7 patients at the 1st visit (1¿3 weeks), by 4 patients at the 2nd visit (4¿7weeks), by 3 patients at the 3rd visit (12¿16 weeks) and by 2 patients at the 4th visit (21¿32 weeks) post-injury.1 patient developed hypesthesia postoperatively.This report is for an unknown synthes synpor.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - SYNPOR IMPLANTS
• Type of Device: ORTHOSIS,PEDICLE,SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8888082
• MDR Text Key: 154424584
• Report Number: 8030965-2019-67153
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention